News

January 29, 2009

Pharmaceutical company Pozen Inc said U.S. health regulators had informed it that showing lesser gastric ulcers was an acceptable main goal for the company's late-stage study of its experimental arthritis drug, sending its shares up as much as 36 percent.

Cadila Healthcare Ltd said on Thursday it has recieved approvals from the U.S. Food & Drug Administration to market three anti-epileptic drugs.

January 26, 2009

U.S. health regulators are reviewing the effectiveness of Plavix (clopidogrel) in some patients.

January 26, 2009

Bristol-Myers Squibb Co and ImClone Systems, which last year was acquired by Eli Lilly and Co, said on Friday they will withdraw, and eventually resubmit, an application with U.S. regulators to market cancer drug Erbitux as a treatment for lung cancer.

January 26, 2009

Drugs for attention deficit hyperactivity disorder can cause children to have hallucinations even when taken as directed, U.S. government researchers said on Monday.

January 23, 2009

The U.S. Food and Drug Administration has cleared the way for the first study of human embryonic stem cell therapy, Geron Corp said on Friday.

January 23, 2009

The U.S. Food and Drug Administration has cleared the way for the world's first study of human embryonic stem cell therapy, Geron Corp said on Friday.

January 23, 2009

European drug regulators have recommended approval for Roche Holding AG's top-selling cancer drug MabThera to treat leukaemia, the Swiss drugmaker said on Friday.

January 22, 2009

European regulators warned on Thursday that Orion's breast cancer drug Fareston should not be used in patients with heart conditions, denting shares in the Finnish drugmaker.

January 21, 2009

GlaxoSmithKline Plc won a final green light on Wednesday to sell its weight-loss drug alli over the counter in Europe, boosting an important area of its consumer healthcare business.

January 21, 2009

Japan's Astellas Pharma Inc and Ono Pharmaceutical Co said on Wednesday they had received approval to sell their osteoporosis drug in Japan, clearing the final hurdle to tap the $770 million market. More than 10 million people in Japan are estimated to suffer from osteoporosis, a disease that weakens bones and increases risk of fracture, and the number is expected to keep growing given the ageing society, the two companies said.

January 21, 2009

Swiss drugmaker Novartis AG said on Wednesday four medicines had been approved in Japan for, respectively, leukaemia, asthma, high blood pressure and an eye disease.

January 21, 2009

Roche Holding AG has won final approval to sell its new rheumatoid arthritis drug, RoActemra, in Europe, the Swiss drugmaker said on Wednesday.

January 16, 2009

Aurobindo Pharma Ltd has secured final U.S. Food and Drug Administration approval to sell generic versions of UCB's seizure drug Keppra in tablet and solution form.

January 16, 2009

India's Orchid Chemicals & Pharmaceuticals Ltd said on Friday it secured final U.S. Food and Drug Administration approval to sell generic levetiracetam tablets in multiple strengths.

January 16, 2009

Indian drug maker Lupin said on Friday it has received final U.S. Food and Drug Administration approval to sell the generic levetiracetam tablet in multiple strengths.

January 16, 2009

India's Glenmark Pharmaceuticals Ltd said on Friday its unit, Glenmark Generics Ltd, has got final U.S. Food and Drug Administration approval to sell generic levetiracetam tablets in multiple strengths.

January 15, 2009

Forest Laboratories Inc and Cypress Bioscience Inc said on Wednesday that the U.S. Food and Drug Administration approved their drug Savella for the management of fibromyalgia.

January 14, 2009

U.S. regulators on Tuesday said their review of clinical trials does not suggest Merck & Co's Singulair asthma drug or similar medicines cause suicide or suicidal thought, although the data were inadequate to draw a firm conclusion.

January 14, 2009

U.S. health regulators have declined to approve Schering-Plough Corp's experimental drug for schizophrenia and bipolar disorder, requesting more data, the drugmaker said on Wednesday.

January 14, 2009

Wyeth said on Wednesday about a dozen European regulators have analyzed data from mid-stage trials of its bapineuzumab drug for Alzheimer's disease and are satisfied that it is appropriate to move ahead with larger late-stage studies.

January 14, 2009

U.S. regulators on Tuesday said their review of clinical trials does not suggest Merck & Co's Singulair asthma drug or similar medicines cause suicide or suicidal thought, although the data were inadequate to draw a firm conclusion.

January 14, 2009

U.S. health regulators have declined to approve Schering-Plough Corp's experimental drug for schizophrenia and bipolar disorder, requesting more data, the drugmaker said on Wednesday.

January 13, 2009

U.S. regulators are continuing to review the safety of Merck & Co's asthma drug Singulair after reports of suicidal behavior, the Food and Drug Administration said on Tuesday.

January 13, 2009

U.S. regulators need to improve lax oversight of the financial conflicts of doctors who test medicines before they are approved for sale, a government watchdog report said on Monday.

January 13, 2009

Santarus Inc, a specialty pharmaceutical company, said U.S. health regulators declined to approve the marketing application for the over-the-counter version of its heartburn drug Zegerid submitted by partner Schering-Plough Corp.

January 12, 2009

U.S. officials finalized controversial guidelines that will allow pharmaceutical companies and medical device makers to tell doctors about unapproved uses of their products.

January 12, 2009

The first drug made using genetically engineered animals to near U.S. approval won key support on Friday from an advisory panel that judged it safe and effective despite concerns from groups worried about the genetic tinkering.

January 9, 2009

U.S. health regulators have again withheld approval for the use of Merck & Co Inc's Gardasil cervical cancer vaccine by women aged 27 to 45, asking for longer-term clinical data, the drugmaker said on Friday.

January 9, 2009

CSL Ltd's experimental treatment for patients with an extremely rare bleeding disorder is safe and effective, a U.S. advisory panel unanimously said on Friday.

January 9, 2009

A U.S. regulatory review of the controversial cholesterol drug Vytorin, made by Merck & Co Inc and Schering-Plough Corp, found the drug works and should still be used, but the positive finding may be too late to win back patients.

January 8, 2009

Wyeth's established drug Enbrel has been approved by the European Commission as the first biologic treatment for children with severe plaque psoriasis, the U.S. company said on Thursday.

January 8, 2009

U.S. regulators have delayed a final decision on whether to approve Eli Lilly and Co's long-acting form of its blockbuster schizophrenia drug Zyprexa, a Food and Drug Administration spokeswoman said on Wednesday.

January 7, 2009

Two proposed therapies to treat rare blood disorders appear safe and effective for U.S. approval, including one produced in genetically engineered goats, Food and Drug Administration staff reviewers said in documents released on Wednesday.

January 7, 2009

French drugmaker Ipsen said on Wednesday U.S. health regulators have extended the date to April 13, 2009, for the initial review of the company's botulinum toxin of type A product, Reloxin.

January 7, 2009

Two proposed therapies to treat rare blood disorders appear safe and effective for U.S. approval, including one made from genetically engineered goats, Food and Drug Administration staff reviewers said in documents released on Wednesday.

January 7, 2009

GTC Biotherapeutics Inc's anti-clotting drug Atryn works and appears safe, U.S. health regulatory staff said in an analysis released on Wednesday.

January 7, 2009

India's Sun Pharmaceutical Industries Ltd said on Wednesday it has secured its first U.S. Food and Drug Administration approval to sell the generic version of a controlled substance in tablet form.

January 6, 2009

Indian drug maker Aurobindo Pharma Ltd said on Tuesday it has received the Canadian regulatory approval to sell its gabapentin capsules in multiple strengths in that country.

January 6, 2009

Ark Therapeutics said on Tuesday that European officials have agreed to accept its brain cancer drug Cerepro for submission.

January 2, 2009

Transgene Biotek Ltd said on Friday it has received a manufacturing licence from the Drug Control Department, Hyderabad for blood cholesterol management products--Orlistat, Lovastatin, Simvastatin, Pravastatin.

January 1, 2009

Merck's popular osteoporosis drug Fosamax and other similar drugs may carry a risk for esophageal cancer, a U.S. Food and Drug Administration official said on Wednesday.

January 1, 2009

Merck's Fosamax and other bisphosphonates may carry a risk for esophageal cancer, a U.S. Food and Drug Administration official said on Wednesday.

December 31, 2008

U.S. health regulators approved Watson Pharmaceuticals Inc's generic version of GlaxoSmithKline Plc's Nicorette mint gum, an over-the-counter product to help smokers quit, Watson said on Wednesday.

December 31, 2008

A U.S. Food and Drug Administration advisory panel will review Eli Lilly's and Daiichi Sankyo's blood-clot preventer prasugrel, the drugmakers said on Wednesday, adding a new hurdle for approval of the potential blockbuster medicine.

December 31, 2008

Akorn-Strides LLC, a joint venture between Akorn Inc and India's Strides Arcolab Ltd, said it received U.S. regulatory approval for two generic antibiotics.

December 31, 2008

Indian drug firm Aurobindo Pharma Ltd said on Wednesday it received the final nod from the U.S. Food and Drug Administration for its stavudine tablets and oral solution.

December 31, 2008

King Pharmaceuticals Inc. said on Wednesday that U.S. health regulators have not yet completed their review of its experimental painkiller Embeda and that the review will likely extend into early 2009.

December 31, 2008

Labopharm Inc said on Wednesday it has won its first U.S. regulatory approval for its once-daily chronic pain drug Ryzolt.

December 30, 2008

Northfield Laboratories Inc said U.S. regulators have granted a priority review for the company's experimental treatment for the loss of red blood cells, sending its shares to a new-year high.

December 29, 2008

Salix Pharmaceuticals Ltd said U.S. health regulators determined the company's bowel drug application cannot be approved in its present form, and that it requires additional clinical data on the drug.

December 29, 2008

Iceland-based generic drug maker Actavis said on Monday it reached an agreement with U.S. health regulators that resolves a Department of Justice complaint over violations of good manufacturing practices at its New Jersey plants.

December 29, 2008

Austrian biotech firm Intercell said on Monday it expects U.S. approval for its Japanese Encephalitis (JE) vaccine to move into early 2009, later than expected.

December 26, 2008

Allergan Inc , the maker of Botox, said on Friday that the U.S. Food and Drug Administration has approved its eyelash-thickening drug Latisse.

December 26, 2008

Allergan Inc, maker of Botox, said on Friday that the U.S. Food and Drug Administration has approved its eyelash-thickening drug Latisse.

December 26, 2008

U.S. regulators have approved Epix Pharmaceuticals Inc's Vasovist imaging agent to help detect blood vessel problems, the U.S. Food and Drug Administration said on Wednesday.

December 24, 2008

U.S. regulators have approved Epix Pharmaceuticals Inc's Vasovist imaging agent to help detect blood vessel problems, the U.S. Food and Drug Administration said on Wednesday.

December 24, 2008

An advertisement for Abbott Laboratories' Humira minimizes the arthritis drug's risks while suggesting it can treat a wider range of patients than it is approved to treat, the U.S. Food and Drug Administration said in a letter released on Tuesday.

December 24, 2008

Drug maker Aurobindo Pharma Ltd said on Wednesday it received the Canadian regulatory approval to sell terbinafine hydrochloride tablets in multiple strengths.

December 24, 2008

AstraZeneca said the U.S. Food and Drug Administration (FDA) had requested further information relating to a supplemental new drug application for its schizophrenia drug Seroquel.

December 24, 2008

Takeda Pharmaceutical Co Ltd, Japan's top drugmaker, said on Wednesday the U.S. Food and Drug Administration would complete a review of a key diabetes drug candidate by June 26, 2009.

December 23, 2008

Haemonetics Corp has failed to correct a variety of manufacturing issues, including taking proper steps to ensure the quality of its blood collection products, the U.S. Food and Drug Administration warned in a letter released on Tuesday.

December 23, 2008

Shares of AMAG Pharmaceuticals Inc fell 20 percent Tuesday, a day after it received a second complete-response letter from U.S. health regulators for its experimental anemia drug, ferumoxytol.

December 22, 2008

U.S. health regulators have approved Novartis' drug Gleevec to reduce the risk of cancer recurring in patients with a rare type of stomach cancer, Novartis said on Friday.

December 22, 2008

Amgen Inc, the world's largest biotechnology company, said on Friday it filed for U.S. Food and Drug Administration approval of experimental drug denosumab as a treatment for osteoporosis in post- menopausal women.

December 22, 2008

Drugmaker Aurobindo Pharma Ltd said on Monday it received the South African regulatory approval to make and market four drugs for treatment for ailments of the central nervous system.

December 19, 2008

Johnson & Johnson said on Friday U.S. regulators have held off making a decision on the company's experimental psoriasis drug ustekinumab until they receive certain risk-mitigation information, but will not require new studies on the promising drug.

December 19, 2008

SkyePharma Plc said talks about the U.S. commercialisation of its asthma treatment Certihaler have ended after advisors to the Food and Drug Administration (FDA) questioned the benefits of the drug.

December 19, 2008

Canadian health officials urged parents on Thursday not to give over-the-counter cold medicines to children under the age of six, citing concern over misuse and overdoses.

December 18, 2008

European regulators on Thursday endorsed the first of a new kind of "micro" vaccine against seasonal flu from Sanofi-Aventis and a pandemic flu shot from Baxter International.

December 18, 2008

Eli Lilly & Co and Daiichi-Sankyo's new blood clot preventer prasugrel won a major endorsement from international regulators on Thursday when the European Medicines Agency recommended its approval.

December 18, 2008

Belgian cancer diagnosis and therapy firm Ion Beam Applications said on Thursday the U.S. Food and Drug Administration approved its Pencil Beam Scanning treatment, which allows for precise treatment delivery.

December 17, 2008

Drug companies should more thoroughly study the potential heart risks of new diabetes medicines, U.S. health officials said on Wednesday.

December 17, 2008

Drug maker Aurobindo Pharma Ltd said on Wednesday the U.S. Food and Drug Administration has tentatively approved its application to sell efavirenz tablets in the United States.

December 16, 2008

U.S. regulators have approved TriLipix, a successor to Abbott Laboratories Inc's blockbuster TriCor medicine used to lower heart-damaging blood fats called triglycerides, the drugmaker said on Monday.

December 16, 2008

Makers of epilepsy drugs must add a warning that the medicines carry a risk of suicidal thoughts or actions, U.S. health officials said on Tuesday.

December 16, 2008

Makers of epilepsy drugs must add a warning that the medicines carry a risk of suicidal thoughts or actions, U.S. health officials said on Tuesday.

December 16, 2008

U.S. Food and Drug Administration Commissioner Andrew von Eschenbach has told staff he will leave the agency on Jan. 20, the day Barack Obama becomes president.

December 16, 2008

U.S. regulators have approved TriLipix, a successor to Abbott Laboratories Inc's blockbuster TriCor medicine used to lower heart-damaging blood fats called triglycerides, the drugmaker said on Monday.

December 16, 2008

Genzyme Corp said on Monday that U.S. health regulators approved its Mozobil drug for stem cell transplantation in patients with the blood cancers non-Hodgkin's lymphoma and multiple myeloma.

December 16, 2008

European Union customs agents seized more than 34 million illegal pills and tablets in the 27-country bloc's first coordinated campaign against illegal medicines, the EU's executive Commission said on Tuesday.

December 16, 2008

Swiss drugmaker Roche Holding AG said it has filed for European approval of Avastin (bevacizumab) for the treatment of patients with previously treated glioblastoma, the most aggressive type of brain cancer.

December 12, 2008

A potentially less-costly version of Female Health Co's condom for women won unanimous backing from a U.S. Food and Drug Administration advisory panel on Thursday.

December 12, 2008

U.S. health regulators are questioning whether clinical trials proposed by ImClone Systems and Amgen Inc will be adequate to show that patients with a certain type of gene are more likely to be helped by two cancer drugs, according to documents released on Friday.

December 12, 2008

Advair (fluticasone and salmeterol; GlaxoSmithKline) and Symbicort (budesonide and formoterol fumarate dihydrate; AstraZeneca) are safe enough for treating asthma, a U.S. advisory panel ruled on Thursday; however, evidence of asthma-related deaths and serious complications led the panel of experts to warn against continued use of Serevent (salmeterol; GlaxoSmithKline) and Foradil (formoterol fumarate inhalation powder; Novartis) for adults, adolescents and children with asthma.

December 12, 2008

A potentially less-costly version of Female Health Co's condom for women won unanimous backing from a U.S. Food and Drug Administration advisory panel on Thursday.

December 12, 2008

GlaxoSmithKline Plc's widely prescribed drug Advair is safe enough for treating asthma but two lesser-used medicines are too risky, a U.S. advisory panel ruled on Thursday.

December 12, 2008

Medtronic Inc will report to the Food and Drug Administration (FDA) the death of a patient who underwent surgery with one of its products, the Wall Street Journal said, citing the Minneapolis-based company.

December 11, 2008

Some sodium-based bowel cleansing products used before colonoscopies can cause kidney damage and must carry a "black box" warning on the packaging, the U.S. Food and Drug Administration said on Thursday.

December 11, 2008

Pain Therapeutics Inc said the U.S. health regulators declined to approve its experimental abuse-resistant painkiller Remoxy in its current form, sending its shares down as much as 29 percent to a new year-low.

December 11, 2008

Danish drugmaker Novo Nordisk said on Thursday it had received a letter from U.S. regulators regarding its once-weekly version of liraglutide, setting out future requirements for extra cardiovascular studies.

December 10, 2008

U.S. drug reviewers presented evidence of life-threatening risks from a class of asthma drugs on Wednesday to an advisory panel considering whether to recommend limits on medicines now used by millions.

December 10, 2008

Chinese leaders meeting to map out economic policy for next year will likely aim to speed medical reform and raise pensions in hopes of encouraging ordinary Chinese to save less, spend more and give the economy a boost.

December 9, 2008

U.S. health regulatory staff have questioned whether there are enough data to show that Female Health Co's latest version of its condom for women prevents pregnancy and sexually transmitted diseases, according to documents released on Tuesday.

December 9, 2008

Targanta Therapeutics Corp said U.S. health regulators declined the approval of its antibiotic and raised questions about the safety of the drug, triggering a 63 percent drop in its shares.

December 9, 2008

U.S. health regulatory staff have questioned whether there are enough data to show that Female Health Co's latest version of its condom for women prevents pregnancy and sexually transmitted diseases, according to documents released on Tuesday.

December 8, 2008

Safety risks with Acusphere Inc's Imagify may be "inappropriate" for use in diagnosing patients with heart problems, U.S. Food and Drug Administration staff said in documents released on Monday, sending the company's shares down 60 percent.

December 8, 2008

U.S. regulators will likely extend their review of Amylin Pharmaceuticals and Eli Lilly's diabetes drug Byetta for use as stand-alone therapy into next year, the companies said on Monday.

December 8, 2008

U.S. regulators will likely extend their review of Amylin Pharmaceuticals and Eli Lilly's diabetes drug Byetta for use as stand-alone therapy into next year, the companies said on Monday.

December 8, 2008

Safety risks with Acusphere Inc's Imagify may be "inappropriate" for use in diagnosing patients with heart problems, U.S. Food and Drug Administration staff said in documents released on Monday.

December 5, 2008

YM BioSciences Inc said its licensee has withdrawn the European marketing application for nimotuzumab, an experimental cancer treatment, citing an inability to address certain quality- and efficacy-related issues within a required time.

December 5, 2008

U.S. regulators remain concerned about serious risks from a class of asthma drugs and will ask U.S. advisers next week if approval for treating the lung disease should be revoked, documents released on Friday said.

December 5, 2008

Aurobindo Pharma Ltd received tentative approval from the US FDA for perindopril erbumine tablets and escitalopram oxalate oral solution, it said in a statement on Friday.

December 5, 2008

U.S. regulators complained that an AstraZeneca PLC sales representative suggested an unapproved use of the company's schizophrenia drug Seroquel to a physician, according to a letter released on Thursday.

December 5, 2008

A study of Genzyme Corp's latest version of its injectable knee pain treatment may be inadequate to weigh how well the product works, U.S. regulatory reviewers said in an analysis released on Friday.

December 5, 2008

APP Pharmaceuticals LLC, the sole provider of heparin in the United States, said it was taking steps to ensure a safe supply after at least 81 deaths and hundreds of other adverse events led to a competitor's recall of the blood thinner in late 2007.

December 4, 2008

Swiss drugmaker Novartis AG's widely-used malaria drug, Coartem, appears safe and effective for use in the United States, a U.S. advisory panel overwhelmingly said on Wednesday.

December 4, 2008

Wockhardt Ltd said on Thursday its U.S. subsidiary, Morton Grove Pharmaceuticals, received US FDA approval to market augmentin suspension, a pediatric drug.

December 4, 2008

Swiss drugmakerRoche Holding AG said on Thursday the European Commission had approved its hepatitis C drug Pegasys for patients whose first round of treatment had not been successful.

December 4, 2008

The contaminant linked to dozens of deaths and hundreds of illnesses from tainted batches of the blood thinner heparin manufactured in China was chemically related to a dietary supplement used to treat joint pain, researchers confirmed on Wednesday.

December 4, 2008

Swiss drugmakerNovartis AG's widely-used malaria drug, Coartem, appears safe and effective for use in the United States, a U.S. advisory panel overwhelmingly said on Wednesday.

December 4, 2008

Spanish pharmaceutical company Zeltia said on Thursday it has submitted an application to the European Medicines Agency to approve its Yondelis drug for the treatment of ovarian cancer.

December 3, 2008

Allergan Inc's drug bimatoprost increased the length, thickness and darkness of eyelashes in a company study, U.S. drug reviewers said in a report released on Wednesday.

December 3, 2008

Solvay Pharmaceuticals Inc does not need to develop additional tests to screen out three new viruses that may be carried in pig proteins used to make its pancreatic enzyme drug Creon, a U.S. advisory panel said on Tuesday.

December 3, 2008

Solvay Pharmaceuticals Inc does not need to develop additional tests to screen out three viruses from its pancreatic enzyme drug Creon, which is made from pig glands, a U.S. advisory panel said on Tuesday.

December 3, 2008

Wyeth has submitted a new childhood meningitis vaccine for approval in Europe, as it battles with GlaxoSmithKline to retain leadership in a multibillion-dollar market.

December 1, 2008

Data show Novartis AG's combination malaria drug Coartem appears to work and causes few serious side effects, U.S. Food and Drug Administration regulatory staff said in documents released on Monday.

December 1, 2008

Novartis is on track to win regulatory approval for its cancer drug Afinitor in the first quarter of 2009, the company's oncology chief told Reuters, adding the drug would be a new blockbuster. "We are on track for approval in the first quarter (of 2009)," David Epstein, in charge of oncology research at the Swiss drug-maker, told Reuters in an interview on Monday.

December 1, 2008

Data show Novartis AG's combination malaria drug Coartem appears to work and causes few serious side effects, U.S. Food and Drug Administration regulatory staff said in documents released on Monday.

November 28, 2008

U.S. health regulators are concerned about the risk of patients contracting viruses from pig glands used to make Solvay Pharmaceuticals Inc's pancreatic enzyme product Creon, according to documents released on Friday.

November 28, 2008

Eli Lilly and Co said on Friday it withdrew its supplemental New Drug Application from U.S. health regulators for Cymbalta, or duloxetine HCl, to manage chronic pain.

November 27, 2008

Sanofi-Aventis' experimental heart drug Multaq will be reviewed by an independent expert panel in the United States next March, marking a delay in a priority review by the health regulator.

November 26, 2008

Roche Holding AG's lung cancer drug Tarceva has won final approval for use by Britain's state health service after the Swiss drugmaker agreed to discount the price of the medicine.

November 26, 2008

Chugai Pharmaceutical, a unit of Roche Holding AG, said on Wednesday that it had filed for an extension for the group's block-buster drug Avastin.

November 26, 2008

U.S. regulators have delayed a decision on approval of an antibiotic from Johnson & Johnson and Basilea, saying they need further audits of clinical sites, the two companies said on Wednesday.

November 26, 2008

Nigeria's drug administration agency has closed down a pharmaceuticals manufacturer in the commercial capital Lagos after contaminated teething syrup killed 25 infants and hospitalised at least 10 more.

November 25, 2008

U.S. health regulators have warned Shionogi & Co Ltd's U.S. unit over misleading promotion of its antibiotic Cedax that omits the drug's risks and makes exaggerated claims, according to a letter released on Tuesday.

November 25, 2008

Biopharmaceutical company Allos Therapeutics said U.S. regulators have granted orphan drug status for its experimental drug to treat diffuse large b-cell lymphoma (DLBCL), a type of cancer.

November 24, 2008

Specialty pharmaceutical company Somaxon Pharmaceuticals Inc said U.S. health regulators extended the review of its experimental insomnia treatment by up to three months.

November 21, 2008

Biopharmaceutical company Dyax Corp said U.S. regulators have granted a priority review for the company's experimental treatment for hereditary angioedema (HAE), a life-threatening genetic disease.

November 21, 2008

The U.S. Food and Drug Administration was hurt by turnover at the top during the George W. Bush administration and needs a strong, independent leader, Pfizer Inc Chief Executive Jeff Kindler said on Thursday.

November 21, 2008

GlaxoSmithKline Plc said on Thursday its new platelet-boosting drug, Promacta, was granted accelerated approval by the U.S. Food and Drug Administration.

November 21, 2008

Glenmark Pharmaceuticals Ltd received approval from the United States Food and Drug Administration for distribution and marketing of Ranitidine tablets in the U.S. market, it said in a statement on Friday.

November 21, 2008

Basilea Pharmaceutica's MRSA superbug antibiotic ceftobiprole has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of complicated skin and soft tissue infections, the Swiss biotech company said on Friday.

November 21, 2008

Swiss drugmaker Roche Holding AG said on Friday its rheumatoid arthritis drug RoActemra had received a positive opinion from the European Committee on Human Medicinal Products (CHMP).

November 20, 2008

A U.S. regulatory panel has voted against recommending approval of Arpida's intravenous antibiotic iclaprim, the Swiss biotech company said on Thursday.

November 20, 2008

Approval for Johnson & Johnson to sell its pain medicine Ionsys in Europe should be suspended because of a defect with the drug's delivery system that could lead to overdose, the European Medicines Agency (EMEA) said on Thursday.

November 20, 2008

U.S. regulators are aiming to meet more drug approval deadlines after what may have been the worst year for evaluating products on time, a senior Food and Drug Administration official said on Tuesday.

November 20, 2008

Rogue manufacturers that produce sub standard or tainted goods will pay for it on their balance sheets, the U.S. Health Secretary said on Thursday.

November 19, 2008

U.S. officials opened the first overseas Food and Drug Administration office in Beijing on Wednesday as they gear up for a long battle to ensure the quality of food, drug and feed imports from China.

November 19, 2008

U.S. regulators have requested more data on Novartis AG's promising cancer drug Afinitor and a decision on approval is expected to be delayed by three months, the Swiss drugmaker said on Wednesday.

November 18, 2008

IDM Pharma Inc said advisors to the European Commission recommended the approval of its experimental treatment for a rare bone cancer, sending its shares soaring as much as 75 percent.

November 18, 2008

IDM Pharma Inc said advisors to the European Commission recommended the approval for marketing approval of its experimental treatment for a rare bone cancer, sending its shares soaring 80 percent in pre-market trade.

November 18, 2008

Merck KGaA, the drugmaker that markets Genentech's psoriasis drug Raptiva in Europe, said it is working with European Union regulators after a second Raptiva patient died of a rare brain infection in the United States.

November 17, 2008

An experimental antibiotic from Theravance Inc may be related to the deaths of some patients who were treated for complicated skin infections in company studies, U.S. drug reviewers said in an analysis released on Monday.

November 17, 2008

Health regulators warned people on Monday not to use an injectable tanning drug because its potential side-effects are unknown.

November 17, 2008

Targanta Therapeutics Corp's clinical trial data show its antibiotic is about as safe and effective as current treatments, Food and Drug Administration staff said on Monday, sending the company's shares up more than 30 percent.

November 17, 2008

Indian generics drugmakerRanbaxy Laboratories has responded to a U.S. probe into procedural violations at two of its Indian plants and expects an early resolution, its chief executive said on Monday.

November 17, 2008

Gilead Sciences Inc said on Friday it has been notified that Teva Pharmaceutical Industries Ltd is seeking U.S. regulatory approval to sell a generic version of Gilead's HIV drug Truvada.

November 14, 2008

U.S. regulators have received reports of serious and unexpected problems in people treated with wrinkle-fighting injections known as dermal fillers, Food and Drug Administration staff said in a report released on Friday.

November 14, 2008

China said on Friday it had recalled a batch of disposable medical needles after one snapped when inserted into an infant's vein, the latest in a string of food and product safety problems.

November 14, 2008

Gilead Sciences Inc plans to appeal a request by the U.S. Food and Drug Administration for an additional clinical study of the company's experimental cystic fibrosis drug, a spokeswoman said on Thursday.

November 13, 2008

AMAG Pharmaceuticals Inc said U.S. health regulators accepted the complete response for its experimental anemia drug, ferumoxytol, sending its shares soaring 86 percent.

November 13, 2008

AstraZeneca Plc has won European approval for wider use of both the original and the new version of its blockbuster schizophrenia drug Seroquel in treating bipolar disorder.

November 13, 2008

Basilea Pharmaceutica's MRSA drug ceftobiprole has received approval in Switzerland, the Swiss biotech company said on Thursday.

November 12, 2008

Clinical trial data from four drugmakers shows no overall risk of heart problems in patients taking certain bisphosphonates to treat osteoporosis, the U.S. Food and Drug Administration said on Wednesday.

November 12, 2008

Clinical trial data from four drugmakers shows no overall risk of heart problems in patients taking certain drugs to treat osteoporosis, the U.S. Food and Drug Administration said on Wednesday.

November 12, 2008

Alpharma Inc's powerful painkiller Embeda may not thwart drug abusers despite design features aimed at curbing misuse, U.S. regulatory staff said in documents released on Wednesday.

November 12, 2008

China has ordered a haemorrhoid medicine off pharmacy shelves over fears the capsules were to blame for liver problems, state media reported on Wednesday.

November 10, 2008

Biotechnology giant Celgene Corp said it received approval from U.S. health regulators to start human testing of its experimental stem-cell therapy for the treatment of Crohn's disease.

November 10, 2008

U.S. drug reviewers could not determine the tamper-resistance properties of an experimental painkiller developed by King Pharmaceuticals and Pain Therapeutics, an analysis released on Monday said.

November 10, 2008

XenoPort Inc said about $23 million in milestone payments from its partners would be delayed, after the new drug application for a drug to treat restless legs syndrome was withdrawn, sending its shares down to a new 52-week low.

November 10, 2008

Discovery Laboratories Inc said the U.S. Food and Drug Administration accepted for review its complete response for Surfaxin, its experimental lung drug for infants, and has set April 17, 2009 as a target action date to complete the review of the drug.

November 7, 2008

China, battling to restore trust in its products amid a tainted milk scandal, has closed a local pharmaceutical company whose herbal injections have been linked to the deaths of three people.

November 7, 2008

Aurobindo Pharma Ltd on Friday said it got final approval from the U.S. Food and Drug Administration to make and market a 20 mg dose of Sertraline Hydrochloride.

November 6, 2008

CV Therapeutics Inc said U.S. health regulators approved its drug Ranexa as a primary treatment for chronic angina, sending its shares up more than 13 percent.

November 6, 2008

U.S. health officials warned doctors and patients on Wednesday that Covidien Ltd was recalling nearly half a million single-use syringes that could pose a serious risk to diabetics.

November 6, 2008

India's Torrent Pharmaceuticals Ltd's generic, risperidone, in tablet forms of various strengths, has got the approval of the U.S. Food and Drug Administration, as per the regulator's website.

November 6, 2008

India's Sun Pharmaceutical Industries Ltd said on Wednesday it had secured U.S. Food and Drug Administration approval to sell the generic version of Sinemet in tablet form, used to treat Parkinson's disease.

November 5, 2008

India's Sun Pharmaceutical Industries Ltd said on Wednesday it had secured U.S. Food and Drug Administration approval to sell the generic version of Sinemet in tablet form, used to treat Parkinson's disease.

November 4, 2008

Strides Arcolab Ltd said on Monday its joint venture with Akron Inc has recieved U.S. FDA approval for Parnidronate Disodium injection.

November 3, 2008

Cephalon Inc won U.S. approval to sell its chemotherapy drug Treanda for treatment of patients with a type of non-Hodgkin's lymphoma, the company said on Friday.

November 3, 2008

Cephalon Inc won U.S. approval to sell its chemotherapy drug Treanda for treatment of patients with a type of non-Hodgkin's lymphoma, the company said on Friday.

November 3, 2008

Strides Arcolab Ltd said on Monday its joint venture with Akron Inc has recieved U.S. FDA approval for Parnidronate Disodium injection.

October 31, 2008

A new drug made by Schwarz Pharma to treat patients with overactive bladders won approval from U.S. health officials on Friday.

October 31, 2008

U.S. regulatory scrutiny over the manufacturing of a Genzyme Corpdrug signals steep hurdles that could await future generic versions of complex biotech medicines.

October 31, 2008

Drugmakers hoping to develop generic drugs made from living cells must be prepared to show they have a complete understanding of how their product works if they want to win U.S. approval, a top Food and Drug Administration scientist said in an interview with Reuters.

October 30, 2008

More than one dozen cases of liver failure and death were reported in patients taking GlaxoSmithKline Plc's Avandia (rosiglitazone), advocacy group Public Citizen said on Thursday in a petition calling for a ban of the drug.

October 30, 2008

Amgen Inc used a misleading brochure to tout its kidney disease drug Sensipar to patients, U.S. health officials said in a letter released on Wednesday.

October 30, 2008

It has been a long time coming but AstraZeneca's blockbuster cholesterol drug Crestor has finally won approval in Germany -- more than five years after its first launch in some other European markets. The Anglo-Swedish company said on Thursday it had secured new marketing authorisation licences this month in Germany, which is Europe's biggest market, as well as Spain, Poland, Norway and Malta.

October 30, 2008

Biogen Idec Inc said on Wednesday that it has notified regulators of a new case of a potentially deadly brain disease in a multiple sclerosis patient being treated with Tysabri in the United States.

October 30, 2008

Amgen Inc used a misleading brochure to tout its kidney disease drug Sensipar to patients, U.S. health officials said in a letter released on Wednesday.

October 29, 2008

Swiss authorities have approved Novartis AG's Rasilez HCT, a single pill combination of two high blood pressure medicines, the drugmaker said.

October 29, 2008

Swiss authorities have approved Novartis AG's Rasilez HCT, a single pill combination of two high blood pressure medicines, the drugmaker said.

October 28, 2008

U.S. health regulators have warned Bayer for selling two over-the-counter aspirin medications that contain dietary supplements without getting approval first, according to documents released on Tuesday.

October 27, 2008

The cardiac device maker Thoratec Corp said wear and fatigue related to its implanted left ventricular assist device may require surgical replacement that could potentially be fatal.

October 27, 2008

Barr Pharmaceuticals Inc said the U.S. regulators approved an oral contraceptive made by its unit Duramed Pharmaceuticals Inc.

October 27, 2008

Shares of Thoratec Corp lost more than half their value after the cardiac device maker said wear and fatigue related to its implanted heart pump may require surgical replacement that could potentially be fatal.

October 27, 2008

The US Food and Drug Administration has issued an alert about complications related to transvaginal placement of surgical mesh devices used to repair pelvic organ prolapse and stress urinary incontinence.

October 24, 2008

The European Medicines Agency has recommended against approval of Eli Lilly and Co's Cymbalta for treating the pain and fatigue condition fibromyalgia.

October 24, 2008

Advisers to the European Commission recommended approval of the Celgene Corpdrug Vidaza as a treatment for a group of blood disorders known as myelodysplastic syndromes, the company said on Friday.

October 24, 2008

Astellas Pharma Inc said on Friday it has withdrawn its submission of a new antibiotic drug candidate in Europe following an unfavourable review by European regulators but hopes to refile with additional data.

October 24, 2008

A committee of experts advising the European Commission said on Friday it backed Merck KGaA's Erbitux drug for a second use to combat head and neck cancer, bolstering its sales potential in the region.

October 24, 2008

Spanish biotechnology group Zeltia said on Friday the U.S. Federal Drug Administration has approved the production strategy for its Aplidin drug for solid tumours.

October 23, 2008

European authorities said on Thursday Sanofi-Aventis's anti-obesity drug Acomplia (rimonabant) should be withdrawn from sale over links to mental disorders.

October 22, 2008

The U.S. Food and Drug Administration's system that monitors inspections of drug manufacturing plants worldwide is outdated and inaccurate, according to a government report released on Wednesday.

October 22, 2008

U.S. health regulators have expanded approval for Johnson & Johnson's Prezista in combination with other drugs to treat HIV patients who are just beginning to take medication for the virus, the company said on Wednesday.

October 22, 2008

Pfizer Inc's smoking-cessation drug Chantix should carry a strong warning about the potential risks of accidental injury and death, U.S. researchers said on Wednesday

October 22, 2008

A mass-produced version of Genzyme Corp's drug to treat the fatal genetic disorder Pompe disease should be approved as long as further studies are required, a U.S. advisory panel said on Tuesday.

October 22, 2008

Antigenics Inc has submitted its Oncophage cancer vaccine for conditional approval in Europe in a move that could open new markets for the product, which is currently only cleared for use in Russia.

October 21, 2008

U.S. regulators have extended by three months their review of a proposed osteoporosis drug from Pfizer Inc, a company spokeswoman said on Tuesday.

October 21, 2008

Safety-related regulatory actions are issued against nearly one in three biological medicinal products within a decade of their approval in Europe and the US, investigators in the Netherlands report in the October 22/29 issue of the Journal of the American Medical Association.

October 21, 2008

U.S. regulators have warned Steris Corp about quality-control violations uncovered during an inspection of a Rhode Island plant, a letter released on Tuesday said.

October 21, 2008

Roche Holding AG is still discussing what additional information is required for approval of its Actemra rheumatoid arthritis drug with U.S. regulators, the Swiss company said on Tuesday.

October 21, 2008

Abbott Laboratories said on Monday that U.S. regulators have withheld approval of its experimental long-acting form of the painkiller Vicodin, leaving it unclear if and when the powerful narcotic might be approved.

October 21, 2008

AstraZeneca Plc is seeking European approval to sell its drug Seroquel XR as a treatment for anxiety, the Anglo-Swedish group said on Tuesday.

October 20, 2008

Discovery Laboratories Inc said it submitted a complete response to the U.S. Food and Drug Administration's concerns on its experimental lung drug for infants.

October 20, 2008

Zydus Cadila said on Monday it has received approval from US Food and Drug Administration to sell Risperidone tablets, which falls in the central nervous system segment.

October 20, 2008

Japan's Takeda Pharmaceutical Co said U.S. regulators have pushed back the possible approval of a key drug candidate, the latest in a string of delays in the world's largest drug market.

October 20, 2008

Forest Laboratories Inc and Cypress Bioscience Inc said on Monday the U.S. Food and Drug Administration was not able to make a decision on whether to approve their fibromyalgia drug by the scheduled date.

October 20, 2008

China has recalled a herbal remedy after it was blamed for the death of a newborn baby, state media said on Monday, in the latest health scare to hit the country.

October 17, 2008

Some U.S. deadlines for reviewing new drugs have come and gone without a decision from the Food and Drug Administration.

October 17, 2008

U.S. health regulators have ordered strong black-box warnings for Genentech Inc's psoriasis drug, Raptiva, saying patients given the once-weekly injections are at risk for life-threatening infections.

October 17, 2008

A mass-produced version of Genzyme Corp's Myozyme showed some similar side effects to a smaller-scale version already on the market, U.S. regulatory staff said in documents released on Friday.

October 17, 2008

Pozen Inc said U.S. health regulators are conducting an internal review on the acceptability of using endoscopic gastric ulcers as a main goal in clinical studies and it was unsure if the review will have any impact on its development programs.

October 16, 2008

Bayer AG said it has won European approval for its contraceptive pill Qlaira.

October 16, 2008

Bayer AG said it has won European approval for Qlaira, a contraceptive pill which it expects to generate sales of up to 500 million euros ($683.1 million) per year.

October 16, 2008

Drug maker Wockhardt Ltd said on Thursday it has received approval from the U.S. Food and Drug Administration to sell generic Ceftazidime injections in a dose of 1 gram per vial.

October 15, 2008

Wyeth has decided against pursuing European approval for its depression treatment for now after consulting with regulators, the company said on Wednesday.

October 14, 2008

Britain's healthcare cost effectiveness watchdog NICE has rebuffed GlaxoSmithKline's latest bid to get its drug Tyverb -- for women with advanced breast cancer -- into the state health system, the company said on Tuesday.

October 14, 2008

U.S. regulators have told medical device maker C.R. Bard Inc to correct manufacturing problems uncovered during an inspection of a plant in Puerto Rico, a letter released on Tuesday said.

October 14, 2008

A Chinese herbal drug suspected of killing three people was "tainted with bacteria", authorities said on Tuesday, underlining the challenge China faces in cleaning up its food and drug sector.

October 13, 2008

Australia's CSL Ltd, the world's top plasma products group, said on Monday the U.S. Federal Trade Commission had asked it for more information on its proposed $3.1 billion takeover of smaller U.S. rival Talecris Biotherapeutics.

October 13, 2008

Indian drug maker Aurobindo Pharma Ltd said on Monday it secured U.S. Food and Drug Administration approval for the anti-psychotic drug risperidone in tablet form.

October 10, 2008

U.S. regulators have approved AstraZeneca's drug Seroquel XR as a treatment for bipolar disorder, extending the medicine's use beyond schizophrenia, the Anglo-Swedish company said on Friday.

October 10, 2008

Aurobindo Pharma Ltd said on Friday it has got final approval from the U.S. Food & Drug Administration to manufacture and market Fluconazole tablets, used for the treatment of fungal infections.

October 10, 2008

Takeda Pharmaceutical Co, Japan's biggest drugmaker, said on Friday that U.S. health authorities have not been able to complete a review of a key diabetes drug candidate on schedule due to lack of resources.

October 9, 2008

China has recalled two batches of herbal injections after three people who used them died, the official Xinhua agency said on Thursday, as the country still struggles to clean up a tainted milk scandal.

October 9, 2008

U.S. health regulators have approved Watson Pharmaceuticals Inc's Rapaflo treatment for urination problems -- a condition known as benign prostatic hyperplasia (BPH), the company said on Wednesday.

October 8, 2008

Laboratory Corp of America is violating the law by selling an ovarian cancer screening test without regulatory approval, U.S. health officials said Wednesday.

October 8, 2008

Laboratory Corp of America is violating the law by selling an ovarian cancer screening test without regulatory approval, U.S. health officials said Wednesday.

October 7, 2008

Two television commercials for Bayer AG's birth control product Yaz are misleading, U.S. health regulators warned the company in a letter released on Tuesday.

October 7, 2008

Early data from a 4-year clinical trial show no increased risk of stroke in patients given Pfizer Inc's lung drug Spiriva compared with placebo, the U.S. Food and Drug Administration said on Tuesday.

October 7, 2008

Oxford Biomedica Plc said U.S. regulators had approved a series of amendments to a study for its lead drug TroVax in renal cancer, being developed alongside French drugmakerSanofi-Aventis.

October 7, 2008

Drug maker Strides Arcolab Ltd said on Tuesday the U.S. Food and Drug Administration had approved its oral dosage manufacturing unit in Bangalore.

October 3, 2008

A study that will cost $3.2 billion and last more than two decades to track the health of 100,000 U.S. children from before birth to age 21 will be launched in January, U.S. health officials said on Friday.

October 3, 2008

Roche's lung cancer drug Tarceva has been recommended for use on Britain's state-funded health service after the Swiss drugmaker agreed to cut the price of the medicine.

October 3, 2008

The U.S. Food and Drug Administration has approved Aurobindo Pharma Ltd's muscle relaxant, cyclobenzaprine hydrochloride tablets, according to the regulator's website.

October 3, 2008

The U.S. Food and Drug Administration has approved Wockhardt Ltd's promethazine hydrochloride injection, the regulator's website showed.

October 2, 2008

Over-the-counter cough and cold medicines should not be sold for young children because they are unproven and can be dangerous, doctors and consumer advocates said on Thursday, despite objections from industry representatives.

October 2, 2008

Medical device maker NeuroMetrix Inc said the U.S. health regulators approved the use of its Universal electrodes in nerve conduction studies, sending its shares up as much as 83 percent.

October 1, 2008

A fast new genetic flu test from Applied Biosystems Inc and the U.S. Centers for Disease Control and Prevention won approval from the U.S. Food and Drug Administration on Tuesday.

October 1, 2008

Bayer's anticoagulant pill Xarelto has been approved by the European Commission for the prevention of blood clots after hip or knee replacement surgery, the German drugmaker said on Wednesday.

September 30, 2008

The European Commission has approved Novartis' osteoporosis drug Aclasta for the use in men and broadened the drug's label, the Swiss drugmaker said on Tuesday.

September 30, 2008

An analysis of dozens of studies found the widely used statin cholesterol drugs do not increase the risk of Lou Gehrig's disease, U.S. health officials said on Monday.

September 30, 2008

French drugmaker Ipsen said on Tuesday the U.S. Food and Drug Administration would not now complete its first-cycle review of its new drug Dysport until the end of the year.

September 29, 2008

Preparations for a biological attack and repeated outbreaks of food poisoning have interfered with efforts by the U.S. Food and Drug Administration to improve the safety of fresh produce, according to a report released on Friday.

September 29, 2008

Biotechnology company Antigenics Inc said it received a license from U.S health regulators to export its kidney cancer vaccine, Oncophage, to Russia.

September 29, 2008

Eli Lilly and Co on Monday said it has won U.S. approval for its drug Alimta as a first-line treatment for patients with advanced lung cancer.

September 29, 2008

U.S. regulators have approved Cepheid's test to rapidly screen for drug-resistant bacterial infections in less than one hour, the company said on Monday.

September 29, 2008

India's Torrent Pharmaceuticals Ltd has received the U.S. Food and Drug Administration approval for anti-hypertension drug amlodipine besylate tablets in multiple strengths, the regulator's website showed on Monday.

September 29, 2008

Eli Lilly and Co and Daiichi Sankyo Co Ltd said on Friday that U.S. health regulators have not completed a review of their closely watched anti-clotting drug prasugrel, leaving the drug's fate in limbo.

September 29, 2008

Eli Lilly, Johnson & Johnson and other drugmakers misled consumers about medicines to treat attention deficit disorder in various sales pitches, U.S. regulators said in letters released on Friday.

September 29, 2008

Indian drugmakerDr. Reddy's Laboratories Ltd has received final approval from the U.S. Food and Drug Administration for nabumetone tablets, the regulator's website showed at the weekend.

September 26, 2008

Excess mortality occurred in patients after treatment with Johnson & Johnson's Eprex (epoetin alfa) in a study testing whether the product could improve brain function in stroke patients, U.S. regulators said on Friday.

September 26, 2008

U.S. health officials said on Friday they were reviewing a higher rate of deaths among patients treated with a Johnson & Johnson anemia drug in a German study of stroke patients.

September 26, 2008

Alphatec Holdings Inc said its Novel Cervical Interbody implant was approved by U.S. health regulators.

September 25, 2008

The European Medicines Agency has recommended approval of Alcon's glaucoma treatment Azarga.

September 25, 2008

The European Medicines Agency has backed approval of Kuvan for treating of hyperphenylalaninemia in patients with phenylketonuria, it said on Thursday.

September 25, 2008

Boston Scientific Corp on Thursday said it won U.S. regulatory approval for its next generation drug-eluting stents.

September 25, 2008

The European Medicines Agency has backed approval of Kuvan, a drug for treating a rare neurological disorder, it said on Thursday.

September 25, 2008

The European Medicines Agency has recommended approval of Alcon's glaucoma treatment Azarga.

September 25, 2008

Boston Scientific Corp on Thursday said it won U.S. regulatory approval for its next generation drug-eluting stents.

September 25, 2008

Belgian drugmaker UCB withdrew its EU application to sell Vimpat, or lacosamide, as a treatment for diabetic neuropathic pain on Thursday after a negative view from the European Medicines Agency.

September 25, 2008

Drugmaker Aurobindo Pharma Ltd said on Thursday it received the U.S. Food and Drug Administration approval to sell didanosine delayed release capsule in multiple strengths in the United States.

September 25, 2008

Glenmark Pharmaceuticals Ltd said on Thursday its generics unit has received approval from the U.S. Food and Drug Administration for sale of betamethasone dipropionate skin cream in the U.S.

September 25, 2008

Ipsen has submitted a six-month sustained version of its prostate cancer treatment Decapeptyl for marketing approval with European health authorities, the French drugmaker said on Thursday.

September 23, 2008

U.S. health officials warned companies on Tuesday to stop selling unapproved versions of an eye-surgery solution and a prescription wound cream that have been linked to serious health problems.

September 23, 2008

U.S. regulators have warned health-care products maker Covidien Ltd about manufacturing problems at a plant in Missouri, a letter released on Tuesday said.

September 23, 2008

India's Sun Pharmaceutical Industries said on Tuesday it had approval from the U.S. Food and Drug Administration to market generic versions of Paraplatin, which is indicated for the treatment of ovarian cancer.

September 18, 2008

Stem Cell Therapeutics Corp said on Thursday it has halted enrollment of patients for a phase II stroke trial in Canada and the United States following a request from health officials in both countries.

September 18, 2008

The U.S. Food and Drug Administration appears to be giving priority to projects that benefit the pharmaceutical industry rather than helping consumers, a top Democratic lawmaker said on Wednesday.

September 18, 2008

Indian generic drugmaker Ranbaxy Laboratories Ltd has hired former New York City Mayor Rudolph Giuliani as an adviser, the company said on Wednesday, one day after regulators banned the U.S. sale of dozens of its drugs.

September 17, 2008

U.S. health officials have banned dozens of drugs made by Ranbaxy Laboratories Ltd after the generic drugmaker failed to fix numerous record-keeping and other operational problems, although the medications themselves are considered safe.

September 17, 2008

GlaxoSmithKline and Roche are both expected to win approval for new drugs in the all-important U.S. market in the coming days, providing a potential boost for their shares.

September 17, 2008

Health officials have banned dozens of drugs made by Ranbaxy Laboratories Ltd after the generic drugmaker failed to fix numerous record-keeping and other operational problems, although the medications themselves are considered safe.

September 16, 2008

Indian drugmakerDr. Reddy's Laboratories Ltd has received approval from the U.S. Food and Drug Administration for galantamine hydrobromide tablets, the regulator's website showed.

September 16, 2008

European authorities have approved Teva Pharmaceutical Industries' biosimilar version of Neupogen, Amgen's best-selling treatment for neutropenia, the Israeli generic drugmaker said on Tuesday.

September 15, 2008

Companies that offer Medicare health insurance and prescription drug coverage can no longer offer free meals during pitches or make unsolicited sales calls, the U.S. government said on Monday.

September 15, 2008

U.S. health regulators have approved Merck and Co's Gardasil vaccine to protect women against vaginal and vulvar cancers, the Food and Drug Administration said Friday.

September 15, 2008

Cephalon Inc said on Monday that U.S. regulators will not allow it to market its painkiller Fentora for anyone other than cancer patients until the company implements enhancements to the drug's risk management program.

September 15, 2008

Cephalon Inc said on Monday that U.S. regulators will not allow it to market its painkiller Fentora for anyone other than cancer patients until the company implements enhancements to the drug's risk management program.

September 15, 2008

U.S. health regulators have approved Merck and Co's Gardasil vaccine to protect women against rare vaginal and vulvar cancers, the Food and Drug Administration said Friday.

September 15, 2008

Swiss drug firm Novartis has won priority review from the U.S. Food and Drug Administration for its Coartem anti-malaria drug.

September 15, 2008

Danish pharmaceutical group Lundbeck said on Monday it had submitted a new drug application for its schizophrenia drug Serdolect to the Food and Drug Administration 10 years after its first attempt.

September 15, 2008

Prostrakan Plc, a UK speciality pharmaceuticals company, has everything it needs to achieve profitability following U.S. approval for its Sancuso cancer patch, according to Chief Executive Wilson Totten.

September 15, 2008

Belgian pharma group UCB said on Monday that U.S. health authorities had approved epilepsy drug Keppra XR and that it would go on sale just before its mother drug loses patent protection.

September 12, 2008

India's Sun Pharmaceutical Industries said it has received approval from the U.S. Food and Drug Administration to market alendronate sodium tablets, the generic version of Merck & Co's Fosamax.

September 12, 2008

Baby formula from China is illegal in the United States and should not be used, U.S. regulators warned on Thursday after Chinese officials blamed tainted formula for the death of an infant.

September 11, 2008

Advanced Medical Solutions Group Plc on Thursday said its silver anti-microbial wound gel had been approved by the U.S. Food & Drug Administration (FDA), sending its shares up 5 percent.

September 9, 2008

An investigational drug from Swiss drugmaker Novartis AG has been granted priority review in the United States as a treatment for advanced kidney cancer.

September 9, 2008

Pfizer Inc is withdrawing all of its marketing applications for its experimental antibiotic for skin infections to conduct further clinical study of the drug.

September 9, 2008

Novartis's new once-a-day kidney cancer pill Afinitor could be approved in the key U.S. market by the end of 2008, the Swiss drugmaker's head of oncology said on Tuesday.

September 9, 2008

Cardica Inc said its PAS-Port proximal anastomosis system for use in cardiac bypass surgery was approved by the U.S. Food and Drug Administration, sending its shares up 27 percent before the bell.

September 9, 2008

An experimental drug from Swiss drugmaker Novartis AG has been granted priority review in the United States as a treatment for advanced kidney cancer.

September 8, 2008

The benefits of a proposed Pfizer Inc drug outweigh the risks for some women with osteoporosis, a U.S. advisory panel decided on Monday.

September 8, 2008

Members of a U.S. advisory panel said on Monday they could not determine if a proposed Pfizer drug for osteoporosis increased the chances of dying.

September 8, 2008

Members of a U.S. advisory panel said on Monday they could not determine if a proposed Pfizer Incdrug for osteoporosis increased the chances of dying.

September 8, 2008

U.S. health regulators have warned Forest Laboratories Inc for promoting its hypertension drug Bystolic without properly noting the medication's risk, according to a letter released on Monday.

September 5, 2008

U.S. health officials have disclosed safety probes into over 20 medicines by companies such as Eli Lilly and Co and Biogen Idec, a step required by Congress to address concerns the agency had been slow to warn of risks.

September 5, 2008

Danish pharmaceuticals group Novo Nordisk said on Friday an assessment by the U.S. Food and Drug Administration of its type 2 diabetes drug Liraglutide is likely to be delayed by some two months.

September 5, 2008

U.S. health officials said on Friday they are probing safety concerns with Eli Lilly and Co's antidepressant Cymbalta, GlaxoSmithKline's cancer drug Tykerb, Biogen Idec and Elan Corp's multiple sclerosis drug Tysabri and other medicines.

September 4, 2008

U.S. health regulators ordered stronger warnings for prescription drugs to treat rheumatoid arthritis, Crohn's disease and other conditions on Thursday after dozens of patients contracted severe fungal infections and died.

September 4, 2008

A higher percentage of patients treated with an experimental Pfizer Incdrug for osteoporosis died during a clinical trial compared with a placebo, U.S. drug reviewers said in an analysis released on Thursday.

September 4, 2008

Belgian pharmaceutical group UCB said on Wednesday that the European Commission has approved its new epilepsy drug Vimpat.

September 4, 2008

Drugmaker Cadila Healthcare said it received approval from the U.S. food & Drug Administration (USFDA) to market its Ramipril capsules used to treat hypertension.

September 4, 2008

Canadian biotechnology company BioMS Medical Corp said on Thursday its lead drug for the treatment of multiple sclerosis was granted fast-track designation from the U.S. Food and Drug Administration.

September 3, 2008

ImClone Systems Inc on Wednesday said it had asked U.S. regulators for permission to market its Erbitux medicine as a first-line treatment for head and neck cancer.

September 3, 2008

Edwards Lifesciences Corp said on Wednesday that it won U.S. regulatory approval for a device to replace diseased mitral valves, one of the most common forms of heart valve abnormalities.

September 3, 2008

Belgian pharmaceutical group UCB said on Wednesday that the European Commission has approved its new epilepsy drug Vimpat.

September 3, 2008

U.S. regulators approved Novartis AG's Omnitrope Pen 10 with liquid cartridge, a copy-cat version of Pfizer Inc's human growth hormone Genotropin.

September 2, 2008

Strides Arcolab Ltd said on Tuesday it has got approval from the U.S. Food and Drug Administration for two more drugs, thereby taking the total approvals to 11.

August 29, 2008

Indian drugmaker Dr Reddy's Laboratories Ltd has received approval from the U.S. Food and Drug Administration for trandolapril tablets, the regulator's website showed.

August 28, 2008

BioDelivery Sciences International Inc said it expects approval for its painkiller ONSOLIS in the first half of 2009, sending shares up as much as 30 percent.

August 27, 2008

U.S. health regulators have called for more data before deciding whether a Johnson & Johnson experimental schizophrenia drug could be sold on the U.S. market, the company said on Tuesday.

August 27, 2008

Novartis's Glivec has received U.S. regulator priority review as the first therapy to reduce the recurrence of gastrointestinal stromal tumours after surgery, the Swiss drugmaker said on Wednesday.

August 27, 2008

Drug developer NexMed Inc said it will not submit a new drug application (NDA) for its nail infection drug based on results of late stage clinical studies, sending its shares down more than 76 percent to their lowest in 13 years.

August 26, 2008

Amylin Pharmaceuticals Inc and Eli Lilly and Co will hold a conference call after U.S. markets close on Tuesday to discuss a recent safety advisory by regulators about the companies' diabetes drug Byetta.

August 26, 2008

U.S. regulators have warned Novartis AG's generic drug unit Sandoz about manufacturing problems at a North Carolina plant, a letter released on Tuesday said.

August 25, 2008

Prescribing instructions for Biogen Idec and Elan Corp's drug Tysabri should be revised to note cases of a serious brain disorder in patients who were using it as their sole treatment for multiple sclerosis, U.S. health regulators said on Monday.

August 25, 2008

Biovail Corp said on Monday it received approval for an expanded indication for once-daily Ralivia, a pain management drug given for adults who need continuous treatment for several days or more.

August 25, 2008

Noven Pharmaceuticals Inc said on Monday that its marketing partner, Shire Ltd, is voluntarily recalling two batches of its skin patch to treat attention-deficit/hyperactivity disorder, because of difficulties removing the release liner when the patch is peeled open.

August 25, 2008

Noven Pharmaceuticals Inc said on Monday that its marketing partner, Shire Ltd, is voluntarily recalling two batches of its skin patch to treat attention deficit hyperactivity disorder because of difficulties removing the release liner when the patch is peeled open.

August 22, 2008

Amgen Inc's drug Nplate is safe and effective for treating a rare clotting disorder that can cause dangerous bleeding, the U.S. Food and Drug Administration said on Friday in approving the product for U.S. sales.

August 21, 2008

Johnson & Johnson said on Thursday U.S. health regulators have requested more information on the company's New Drug Application for Doribax to treat hospital-acquired pneumonia.

August 21, 2008

Drugmaker Aurobindo Pharma Ltd said on Thursday it received a tentative approval from the U.S. Food and Drug Administration for its generic losartan potassium tablets in multiple strengths.

August 21, 2008

Home Diagnostics Inc, said it received approval from U.S. health regulators for its blood glucose meter, TRUE2go, and for TRUEresult, its no-coding meter for at-home testing.

August 21, 2008

Celgene Corp said on Thursday that U.S. regulators have given it the green light to add information to the label of its drug Vidaza showing it prolonged life in some patients with myelodysplastic syndromes, or MDS, a group of blood disorders that can lead to leukemia.

August 20, 2008

U.S. health regulators warned of more cases of dangerous pancreas inflammation in patients taking Amylin Pharmaceuticals Inc's diabetes drug, Byetta, pounding company shares on fears of lower sales and doubts about a new version of the medicine.

August 19, 2008

The Food and Drug Administration has warned GE Healthcare's Integrated IT Solutions unit about a dozen manufacturing violations including improper record keeping that could result in further action from the agency.

August 18, 2008

U.S. health regulators are seeking stronger warnings about the risk of pancreatitis after the deaths of two patients taking Amylin Pharmaceuticals Inc's injectable diabetes drug Byetta (exenatide).

August 18, 2008

U.S. health regulators are seeking stronger warnings about the risk of pancreatitis after the deaths of two patients taking Amylin Pharmaceuticals Inc's injectable diabetes drug Byetta, sending the company's shares down as much 16 percent.

August 18, 2008

PreMD Inc lost more than half of its value on Monday after the U.S. Food and Drug Administration upheld an earlier decision to not approve expanded use of its skin cholesterol test, casting doubt over the future of the small Canadian biotechnology firm.

August 15, 2008

Boston Scientific Corp is recalling its NexStent carotid artery products because part of the stent's delivery system can detach and cause injury, U.S. health officials said on Thursday.

August 15, 2008

U.S. health officials have approved the first drug aimed at easing symptoms of Huntington's disease. The drug, called Xenazine, is intended to reduce involuntary body movements that can increase as the disease progresses, the U.S. Food and Drug Administration said on Friday.

August 15, 2008

Boston Scientific Corp is recalling its NexStent carotid artery products because part of the stent's delivery system can detach and cause injury, U.S. health officials said on Thursday.

August 13, 2008

The European Medicines Agency said on Wednesday it was assessing two cases of a potentially deadly brain disease reported last month in multiple sclerosis (MS) patients being treated with the drug Tysabri.

August 13, 2008

A change in how the United States responds to drug applications threatens to add more uncertainty for investors trying to gauge if a new medicine will reach the world's largest pharmaceutical market.

August 12, 2008

Gilead Sciences Inc said on Monday it won U.S. approval to promote its anti-HIV drug Viread (tenofovir) for treating adults with chronic hepatitis B.

August 12, 2008

Nearly 200 patients given Alkermes Inc's drug Vivitrol (naltrexone) for alcohol dependence reported complications from the injection, including abscesses requiring surgical drainage, U.S. health regulators warned on Tuesday.

August 12, 2008

A change in how the United States responds to drug applications threatens to add more uncertainty for investors trying to gauge if a new medicine will reach the world's largest pharmaceutical market.

August 12, 2008

Nearly 200 patients given Alkermes Inc's drug Vivitrol for alcohol dependence reported complications from the injection, including abscesses requiring surgical drainage, U.S. health regulators warned on Tuesday.

August 12, 2008

Indian drugmakerCipla Ltd has received approval from the U.S. Food and Drug Administration to market ramipril capsules, the regulator's website showed.

August 12, 2008

Gilead Sciences Inc said on Monday it won U.S. approval to promote its AIDS drug Viread for treating adults with chronic hepatitis B.

August 12, 2008

U.S. regulators will review on a priority basis an experimental abuse-resistant painkiller from King Pharmaceuticals Inc and Pain Therapeutics Inc, the companies said on Tuesday.

August 11, 2008

Shares of Cardiome Pharma Corp fell more than 25 percent on Monday after the company said U.S. regulators required more information on its Kynapid treatment for atrial fibrillation, a potentially fatal heart condition.

August 11, 2008

Aurobindo Pharma Ltd said on Monday it has received a final approval from the US Food and Drug Administration (USFDA) for its cefazolin injection, belonging to a class of antibiotic called cephalosporins.

August 11, 2008

Indian drugmakerDr. Reddy's Laboratories Ltd has received approval from the U.S. Federal Drug Administration to make and market alendronate sodium tablets, the regulator's website showed.

August 8, 2008

U.S. health officials warned the public on Friday about the risk of a rare type of muscle injury seen when the cholesterol drug simvastatin is combined with the anti-arrhythmia medicine amiodarone.

August 8, 2008

The Food and Drug Administration said on Friday it continued to receive reports of rhabdomyolysis when simvastatin is combined with amiodarone, despite a 2002 warning about combining the drugs.

August 8, 2008

U.S. health regulators have extended their review of Johnson & Johnson's experimental psoriasis drug, ustekinumab, by three months, the company's Centocor unit said on Friday.

August 8, 2008

U.S. health officials warned the public on Friday about the risk of a rare type of muscle injury seen when the cholesterol drug simvastatin is combined with the anti-arrhythmia medicine amiodarone.

August 8, 2008

Sanofi-Aventis's experimental heart drug Multaq, which some analysts believe could be worth more than $2 billion in sales a year, is to get a priority review from the U.S. Food and Drug Administration.

August 7, 2008

Denmark's Novo Nordisk said it does not expect U.S. health regulators to require it to conduct cardiovascular trials for its diabetes drug liraglutide prior to regulatory approval.

August 7, 2008

UK-listed medical imaging software company Medicsight Plc said it has won approval from the Brazilian regulatory agency, Agencia Nacional de Vigilancia Sanitaria, for its ColonCAD tumour detection software.

August 5, 2008

U.S. health authorities have lifted the ban on Swiss dental implant maker Straumann's Biora products, the company said on Tuesday.

August 5, 2008

Drugmaker Aurobindo Pharma Ltd said on Tuesday it received the U.S. Food and Drug Administration's approval to launch multiple forms of alendronate sodium tablets in that country.

August 5, 2008

Drug maker Venus Remedies Ltd said on Tuesday it received the European certification for two of its cancer drugs making units, allowing it entry into the regulated markets of Europe.

August 4, 2008

Medicines Co said the U.S. Food and Drug Administration approved its injectable blood pressure drug, Cleviprex, sending its shares up as much as 6% to its highest level in more than a year.

August 1, 2008

Schering-Plough Corp said on Friday U.S. regulators had rejected Bridion, its drug to reverse the effects of anesthesia that had been heralded as a breakthrough product by analysts and was unanimously recommended by a federal advisory panel.

August 1, 2008

The House Energy and Commerce committee wants the U.S. Food and Drug Administration to turn over the results of an analysis about the potential links between cancer and cholesterol drug Vytorin, the Wall Street Journal reported.

August 1, 2008

Drug maker Cadila Healthcare Ltd said on Friday it received the U.S. Food and Drug Administration approval for its generic bromocriptine mesylate capsules.

July 31, 2008

U.S. regulators approved Affymetrix Inc software technology that uses a genetic test that may help identify deadly types of cancer cells, sending the company's shares up more than 7 percent on Thursday.

July 31, 2008

U.S. health officials ordered Amgen Inc on Wednesday to add new warnings to its widely used anemia drug Aranesp and similar medicines about the serious risks to cancer patients.

July 30, 2008

The backlog of pending generic drug applications is likely to top 1,500 this year and climb further unless the U.S. Food and Drug Administration receives more funding, a top agency official told Reuters on Wednesday.

July 30, 2008

European regulators have approved a breakthrough new medication to help patients emerge far more quickly from anesthesia than existing treatments, the drug's maker Schering-Plough Corp said on Tuesday.

July 30, 2008

U.S. health regulators have approved several generic competitors to Abbott Laboratories' delayed-acting, anti-seizure drug Depakote, officials said on Tuesday.

July 30, 2008

European regulators have approved a breakthrough new medicine to help patients emerge far more quickly from anesthesia than existing treatments, Schering-Plough Corp, the maker of the medicine, said on Tuesday.

July 30, 2008

Bayer AG's key new anticoagulant drug Xarelto has been submitted for approval in the United States by its partner Johnson & Johnson.

July 29, 2008

Roche Holding AG's drug Actemra should be approved for treating moderate or severe rheumatoid arthritis, a U.S. advisory panel said Tuesday in a 10-1 vote.

July 29, 2008

Belgian pharmaceutical group UCB has received a "not approvable" letter from the U.S. Food and Drug Administration for its drug lacosamide to treat diabetic neuropathic pain in adults.

July 28, 2008

Shares of Vanda Pharmaceuticals Inc hit a lifetime low on Monday, after it said it received a not-approvable letter from U.S. regulatory authorities for its treatment of schizophrenia, and added that with current capital available additional tests would not be possible.

July 28, 2008

Widespread sloppiness at both Canada's nuclear regulator and government-owned Atomic Energy Canada Ltd prompted the damaging closure of a reactor which made medical radioisotopes, a report said on Monday.

July 28, 2008

Roche has submitted an application to the European Medicines Agency (EMEA) to extend its label of breast-cancer drug Avastin so that it can be used with docetaxel chemotherapy, the drugmaker said on Monday.

July 28, 2008

Germany's GPC Biotech AG said on Friday that the European marketing application for its experimental prostate cancer drug satraplatin would be withdrawn.

July 25, 2008

Roche Holding AG's drug Actemra appears to help adults with rheumatoid arthritis, U.S. drug reviewers said in a summary released on Friday ahead of a key meeting on the product.

July 25, 2008

The European Medicines Agency has recommended extended use of Takeda Pharmaceutical Co and Johnson & Johnson's Velcade (bortezomib) for certain people with previously untreated multiple myeloma, the London-based watchdog said on Friday.

July 25, 2008

The European Medicines Agency has recommended against extended use of Sanofi Aventis' drug Taxotere to treat HER2-positive breast cancer, the London-based watchdog said on Friday.

July 25, 2008

The European Medicines Agency has recommended using Novartis AG's bone drug Aclasta in men at risk of bone fracture as well as women, the London-based watchdog said on Friday.

July 25, 2008

Roche Holding AG's drug Actemra appears to help adults with rheumatoid arthritis, U.S. drug reviewers said in a summary released on Friday ahead of a key meeting on the product.

July 25, 2008

The European Medicines Agency has recommended using Novartis AG's bone drug Aclasta in men at risk of bone fracture as well as women, the London-based watchdog said on Friday.

July 25, 2008

The European Medicines Agency has recommended against extended use of Sanofi Aventis' drug Taxotere to treat HER2 positive breast cancer, the London-based watchdog said on Friday.

July 25, 2008

The European Medicines Agency has recommended extended use of Takeda Pharmaceutical Co and Johnson & Johnson's cancer drug Velcade for certain people with previously untreated multiple myeloma, the London-based watchdog said on Friday.

July 24, 2008

HIV patients should be given a genetic test before treatment with GlaxoSmithKline Plc's drug, Ziagen (abacavir), to see if they face a higher risk of a potentially fatal reaction, U.S. regulators said on Thursday.

July 24, 2008

The European Medicines Agency has recommended limiting the use of oral moxifloxacin-containing medicines after finalizing a review of the safety of the antibiotics, the agency said on Thursday.

July 24, 2008

AIDS patients should be given a genetic test before treatment with GlaxoSmithKline Plc's drug, Ziagen, to see if they face a higher risk of a potentially fatal reaction, U.S. regulators said on Thursday.

July 24, 2008

Piramal Healthcare Ltd has got a licence from the Indian government to manufacture Codeine, a narcotic substance, and expects to put up a plant in three years, Chairman Ajay Piramal said on Thursday.

July 23, 2008

British doctors should slash the number of times they prescribe antibiotics for respiratory tract infections because the drugs rarely help, the country's drug cost watchdog said on Wednesday.

July 23, 2008

Two leading U.S. Democrats said on Tuesday they are investigating whether Food and Drug Administration knowingly allowed the sale of Ranbaxy drugs that may have been backed by fraudulent data.

July 22, 2008

U.S. drug regulators said on Monday they are reviewing the latest data that found Schering-Plough Corp and Merck & Co Inc's drug Vytorin failed to improve heart outcomes in a widely-watched clinical study.

July 22, 2008

U.S. regulators have warned Anika Therapeutics Inc about manufacturing problems uncovered during a March inspection of a plant in Woburn, Massachusetts, a letter released on Tuesday said.

July 17, 2008

Astellas Pharma Inc said on Thursday it had won approval to sell a new version of its key transplant drug in Japan, the second major region where it has gained approval although it is facing delays in the United States.

July 17, 2008

Labopharm Inc inched closer to U.S. approval of the once-daily version of its Tramadol pain treatment on Thursday, after the Food and Drug Administration accepted the analysis provided by the Canadian drug company.

July 17, 2008

Johnson & Johnson's antibiotic Doribax appears safe and effective for treating patients with pneumonia acquired in a hospital, a U.S. Food and Drug Administration advisory panel said on Wednesday.

July 17, 2008

Astellas Pharma Inc said on Thursday it had won approval to sell a new version of its key transplant drug in Japan, the second major region where it has gained approval although it is facing delays in the United States.

July 16, 2008

Johnson & Johnson's antibiotic Doribax appears effective for treating patients with pneumonia acquired during a hospital stay, a U.S. advisory panel said in a 7-6 vote on Wednesday.

July 15, 2008

Denmark's Novo Nordisk, the world's biggest maker of insulin, said on Tuesday it filed for regulatory approval for its diabetes drug liraglutide in Japan.

July 14, 2008

U.S. drug reviewers have "several major concerns" about effectiveness data supplied by Johnson & Johnson in a bid to expand use of its antibiotic Doribax (doripenem for injection), according to documents released on Monday.

July 14, 2008

Orthopedic device maker Zimmer Holdings Inc on Monday said it notified U.S. health regulators that it is recalling a surgical instrument used in implanting its NexGen replacement knee product.

July 14, 2008

Orthopedic device maker Zimmer Holdings Inc on Monday said it notified U.S. health regulators that it is recalling a surgical instrument used in implanting its NexGen replacement knee product.

July 14, 2008

Amgen Inc said on Monday that a press release announcing U.S. approval of its drug to treat patients with low levels of blood platelets was inaccurate, and that the medicine, Nplate, is still under regulatory review.

July 14, 2008

U.S. drug reviewers have major concerns about effectiveness data supplied by Johnson & Johnson in a bid to win approval for wider use of its Doribax antibiotic, documents released on Monday said.

July 11, 2008

Anti-seizure drugs for treating epilepsy carry an increased risk of suicidal thoughts and behavior, but not enough to warrant a black box warning, a U.S. advisory panel concluded on Thursday.

July 11, 2008

Merck & Co said on Friday its cholesterol drug that was rejected by U.S. health regulators earlier this year was approved by the European Union.

July 11, 2008

Momenta Pharmaceuticals Inc said on Friday U.S. regulators had accepted for review its generic version of Teva Pharmaceutical Industries Ltd's multiple sclerosis drug Copaxone, sending Momenta shares up nearly 12 percent.

July 11, 2008

Anti-seizure drugs for treating epilepsy carry an increased risk of suicidal thoughts and behavior, but not enough to warrant a black box warning, a U.S. advisory panel concluded on Thursday.

July 11, 2008

AngioDynamics Inc said it was voluntarily recalling Centros, its self-centering central venous catheter for dialysis, but expects the total costs associated with the recall to be minimal.

July 11, 2008

Pfizer Inc said its epilepsy drugs do not increase the risk of suicidal behavior and should be exempt from tougher warnings being sought for similar medications.

July 11, 2008

Pfizer Inc said its epilepsy drugs do not increase the risk of suicidal behavior and should be exempt from tougher warnings being sought for similar medications.

July 11, 2008

Vaccine maker Panacea Biotec Ltd said on Thursday its combination pentavalent vaccine, EasyFive, had received the World Health Organization's pre-qualification.

July 10, 2008

U.S. regulators will change the way they tell drugmakers that their medicines are not ready to be approved, the Food and Drug Administration said on Wednesday.

July 10, 2008

Use of antibiotic drugs such as Bayer AG's Cipro can lead to tendinitis and ruptured tendons, U.S. health regulators said on Tuesday, calling for new strong warnings on the products.

July 9, 2008

Use of antibiotic drugs such as Bayer AG's Cipro can lead to tendinitis and ruptured tendons, U.S. health regulators said on Tuesday, calling for new strong warnings on the products.

July 9, 2008

The U.S. Food and Drug Administration on Tuesday approved Invitrogen Corp's genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin.

July 9, 2008

Use of fluoroquinolone antibiotics can lead to tendinitis and ruptured tendons, U.S. health regulators said on Tuesday, calling for new "black box" warnings on the products.

July 8, 2008

U.S. Food and Drug Administration officials will seek a strong "black box" warning for epilepsy drugs cautioning about the risk of suicidal thoughts and behavior, agency spokeswoman Sandy Walsh told Reuters on Monday.

July 8, 2008

U.S. Food and Drug Administration officials will seek a strong "black box" warning for epilepsy drugs cautioning about the risk of suicidal thoughts and behavior, an agency spokeswoman told Reuters on Monday.

July 4, 2008

Wyeth and Progenics Pharmaceuticals Inc won European approval for Relistor, a drug used to treat constipation that occurs with the use of opioid painkillers, like morphine, the companies said on Thursday.

July 4, 2008

Adolor Corp said U. S. health regulators lifted a clinical hold on its drug Entereg, which is being developed to treat bowel dysfunction in patients on opioid therapy, but said partner GlaxoSmithKline may be mulling dropping out of their development deal.

July 4, 2008

Abbott Laboratories Inc's drug-coated coronary stent, called Xience, won approval on Wednesday, becoming the latest entry into a multibillion-dollar market that includes devices sold by Johnson & Johnson, Boston Scientific and Medtronic Inc.

July 4, 2008

Adolor Corp said U. S. health regulators lifted a clinical hold on its drug Entereg, which is being developed to treat bowel dysfunction in patients on opioid therapy, but said partner GlaxoSmithKline may be mulling dropping out of their development deal.

July 4, 2008

Abbott Laboratories Inc's drug-coated heart stent became the latest entry into a sector still recovering from safety concerns over potentially fatal blood clots, winning approval on Wednesday.

July 3, 2008

Drug makers should do more testing to see if proposed new diabetes medicines may damage patients' hearts, a prominent cardiologist told a U.S. advisory panel on Tuesday.

July 3, 2008

Bone growth products made by Medtronic Inc and Stryker Corp have been linked to life-threatening complications when used without approval in neck fusion surgeries, the U.S. Food and Drug Administration warned on Tuesday.

July 3, 2008

Drug maker FDC Ltd said on Wednesday it received the U.S. Food and Drug Administration approval for ciprofloxacin ophthalmic solution.

July 2, 2008

Indian drug maker Cipla Ltd has received approval from the U.S. Food and Drug Administration for AIDS drug zidovudine syrup, the regulator's Web site showed. (Reporting by Rina Chandran; Editing by Ranjit Gangadharan)

July 1, 2008

Takeda Pharmaceutical Co Ltd said it had submitted to Japan's health ministry a drug application for anti-cancer agent panitumumab for the treatment of colorectal cancer patients.

July 1, 2008

GlaxoSmithKline Plc does not expect to win U.S. approval for its key cervical cancer vaccine Cervarix until late 2009, marking a further delay for the product.

July 1, 2008

Labopharm Inc said on Monday that the U.S. Food and Drug Administration has denied the company's appeal of the regulator's decision on its once-daily pain formula tramadol.

July 1, 2008

Pfizer Inc said on Monday that U.S. health regulators approved its long-acting pet antibiotic, Convenia, to treat most common skin infections in dogs and cats.

July 1, 2008

Basilea's superbug drug ceftobiprole received approval for the first time after Canadian health authorities gave it the green light, the Swiss biotech company said on Monday, pushing its shares higher.

June 28, 2008

Vaccine and drug maker Panacea Biotec Ltd expects to get World Health Organisation's pre-qualification for its pentavalent combination vaccine in July-Sept quarter, its joint managing director said.

June 28, 2008

Merck & Co Inc and Schering-Plough Corp said on Friday they withdrew their U.S. application for combining their blockbuster allergy drugs Singulair and Claritin into one pill, and ended an eight-year joint effort on the respiratory drugs.

June 28, 2008

Johnson & Johnson said on Friday U.S. health regulators approved Concerta to treat adults with attention deficit hyperactivity disorder, or ADHD.

June 28, 2008

Johnson & Johnson said on Friday U.S. health regulators approved Concerta (methylphenidate) to treat adults with attention deficit hyperactivity disorder, or ADHD.

June 28, 2008

U.S. health officials are weighing tougher requirements for companies looking to launch new entries into the lucrative market for diabetes drugs.

June 27, 2008

The European Medicines Agency has recommended approval of UCB's new epilepsy drug Vimpat, the London-based watchdog said on Thursday.

June 27, 2008

Actelion's top-selling drug Tracleer has been recommended for wider use in Europe, in a move that could boost its commercial potential.

June 27, 2008

The European Medicines Agency has issued new warnings related to the risk of fibrosis for five ergo-derived dopamine agonists to treat Parkinson's disease, the drugs watchdog said on Thursday.

June 27, 2008

Roche Holding AG said on Thursday it had received European Union approval for a shortened treatment course for Pegasys in combination with Copegus for certain hepatitis C patients.

June 26, 2008

Makers of contrast agents used to enhance echocardiograms need to conduct larger studies to better evaluate the heart risks seen in some patients, a U.S. panel of medical experts said on Tuesday.

June 26, 2008

U.S. regulators have told Merck & Co they cannot yet approve Merck's application to expand marketing of its cervical cancer vaccine Gardasil to an older group of women, the drugmaker said on Wednesday.

June 26, 2008

India's Ranbaxy Laboratories Ltd said it had received tentative approval from the U.S. Food and Drug Administration for the generic version of Roche's anti-viral Valcyte, saying it believed it was the first to file.

June 26, 2008

U.S. regulators have told Merck & Co they cannot yet approve Merck's application to expand marketing of its HPV vaccine Gardasil to an older group of women, the drugmaker said Wednesday.

June 25, 2008

Denmark's Novo Nordisk said on Tuesday it had received approval from the U.S. Food and Drug Administration for PrandiMet, a fixed-dose combination of an insulin and an insulin sensitiser for type 2 diabetes.

June 25, 2008

Denmark's Novo Nordisk said on Tuesday it had received approval from the U.S. Food and Drug Administration for PrandiMet, a fixed-dose combination of an insulin and an insulin sensitiser for type 2 diabetes.

June 25, 2008

U.S. regulators have extended the review period for Eli Lilly and Co and Daiichi Sankyo's new blood-thinning drug prasugrel, delaying a decision on approval by three months.

June 25, 2008

Japanese drug maker Daiichi Sankyo and Eli Lilly and Co said on Tuesday the U.S. Food and Drug Administration has extended the review period for an application of its blood thinner prasugrel by three months.

June 25, 2008

Dutch biotechnology firm Pharming is confident it can convince European authorities of the efficacy of its key Rhucin drug with new tests and get it approved, a senior company executive said on Tuesday.

June 24, 2008

The U.S. Food and Drug Administration has become faster since 2002 at approving applications from makers of medical devices, according to an agency report released on Monday.

June 24, 2008

Warner Chilcott Ltd said it received approval from the U.S. Food and Drug Administration for the 150mg dosage of its Doryx Delayed-Release tablets used for treating severe acne.

June 24, 2008

Unichem Laboratories Ltd said on Monday it has got approval from the U.S. Food and Drug Administration for its formulations plant in the northern state of Uttar Pradesh.

June 24, 2008

Takeda Pharmaceutical Co, Japan's largest drugmaker, won U.S. approval to promote its cancer drug Velcade for earlier treatment of multiple myeloma, the company said on Friday.

June 24, 2008

Japanese drug maker Astellas Pharma Inc said on Monday it was seeking approval for an additional application of its key transplant drug in Japan.

June 21, 2008

U.S. drug regulators are close to allowing doctors to electronically prescribe potentially abusive medications like painkillers, rather than requiring written orders, a Drug Enforcement Administration spokeswoman said on Thursday.

June 21, 2008

Merck & Co said on Friday it may have to wait until 2013 before the U.S. Food and Drug Administration will consider its experimental medicine for raising good cholesterol, which the FDA rejected in April.

June 21, 2008

Glenmark Pharmaceuticals Ltd said on Friday its unit, Glenmark Generics Ltd, has started selling trandolapril tablets in the United States following approval from the U.S. Food and Drug Administration.

June 19, 2008

U.S. health officials should approve wider use of Amgen Inc's drug Enbrel to treat psoriasis in children, a Food and Drug Administration advisory panel said on Wednesday.

June 18, 2008

Older, conventional antipsychotic medications should carry a "black box" warning about an increased risk of death in some elderly people being treated for dementia-related psychosis, the Food and Drug Administration said Monday.

June 18, 2008

The European Medicines Agency said on Tuesday that information about lung cancer should be added to the label for Pfizer Inc's inhaled insulin drug Exubera, due to increased cases in patients taking the product.

June 18, 2008

Chattem Inc failed to notify U.S. health officials about new warnings added to its Icy Hot heat therapy patches after getting more than 168 complaints, according to a letter released on Tuesday, sending shares down as much as 5 percent.

June 18, 2008

U.S. regulators on Monday updated the number of deaths of patients who took heparin, nearly doubling it to 149, but said they could not link the deaths to contaminated forms of the blood-thinning drug.

June 18, 2008

Consumers should beware of products sold on the Internet that claim to cure cancer, U.S. health officials said on Tuesday, threatening penalties against more than two dozen companies selling creams, tea and pills as treatments for the disease.

June 18, 2008

Australia said on Tuesday it had approved the first locally made vaccine to protect humans from future bird flu, giving the nod to Panvax manufactured by CSL.

June 17, 2008

U.S. drug regulators are concerned about life-threatening complications in children taking Amgen Inc's drug Enbrel for psoriasis and other conditions, according to documents released on Monday.

June 17, 2008

Eli Lilly and Co said Monday its antidepressant Cymbalta won U.S. approval for addressing the pain condition fibromyalgia, opening up a new market that could propel the drug's sales.

June 17, 2008

Indian drug maker Lupin Ltd said on Monday its unit had got a tentative U.S. Food and Drug Administration approval to make and market escitalopram oxalate tablets.

June 17, 2008

U.S. drug regulators are concerned about life-threatening complications in children taking Amgen Inc's drug Enbrel for psoriasis and other conditions, according to documents released on Monday.

June 17, 2008

Older, conventional antipsychotic medications can increase the risk of death in some elderly patients, the U.S. Food and Drug Administration warned on Monday.

June 14, 2008

An experimental psoriasis drug from Johnson & Johnson is effective at relieving symptoms but extended use may raise the risk of cancer, U.S. drug reviewers said in documents released on Friday.

June 14, 2008

The U.S. Food and Drug Administration failed to review on time nearly half the applications from generic drug makers seeking approval to sell cheaper versions of brand-name pharmaceuticals, according to a government report released on Friday.

June 14, 2008

An experimental psoriasis drug from Johnson & Johnson was effective in clinical trials, but long-term use may increase the risk of cancer, U.S. drug reviewers said in documents released on Friday.

June 13, 2008

Epilepsy drugs are associated with a higher risk of suicidal thoughts and behavior, U.S. drug reviewers said in an analysis that was released on Wednesday and mirrored earlier findings.

June 13, 2008

U.S. regulators have granted tentative approval to Teva Pharmaceutical Industries Ltd's generic form of Novartis AG's blockbuster high blood pressure drug Diovan, Teva said on Thursday.

June 13, 2008

GlaxoSmithKline Plc has received formal European marketing authorisation for its new breast cancer pill Tyverb, the drugmaker said on Thursday.

June 13, 2008

Federal health officials have not followed through on a promise made last year to improve the safety of the U.S. food supply, lawmakers and others said Thursday, as investigators work to determine the extent of the latest foodborne illness linked to tomatoes.

June 13, 2008

GE Healthcare, a unit of General Electric Corp, said on Thursday U.S. health regulators granted it priority review on its application for AdreView, a molecular imaging agent for the detection of neuroendocrine tumors in children and adult patients.

June 13, 2008

GlaxoSmithKline Plc has received formal European marketing authorisation for its new breast cancer pill Tyverb, the world's second biggest drugmaker said on Thursday.

June 13, 2008

Epilepsy drugs are associated with a higher risk of suicidal thoughts and behavior, U.S. drug reviewers said in an analysis that was released on Wednesday and mirrored earlier findings.

June 12, 2008

Indian drug maker Lupin Ltd said on Wednesday it had approval from the U.S. Food and Drug Administration to market ramipril capsules in multiple strengths.

June 12, 2008

Drug maker Unichem Laboratories Ltd said on Wednesday it received the U.S. Food and Drug Administration approval for sale of insomnia drug, zaleplon, in capsule form.

June 10, 2008

Shire Plc has again recalled some of its attention deficit hyperactivity disorder (ADHD) skin patches because of problems with removing the liners covering them, the company said on Monday.

June 10, 2008

Shire Plc has again recalled some of its attention deficit hyperactivity disorder (ADHD) skin patches because of problems with removing the liners covering them, the company said on Monday.

June 7, 2008

The European Medicines Agency, already responsible for approving nearly all new medicines in Europe, may also start evaluating medical devices within a few years, its executive director said on Friday. Thomas Lonngren said legislation under discussion in Brussels could well result in the agency being asked to assess high-risk devices.

June 7, 2008

A growing number of new drugs for cancer and other conditions are likely to be approved but not reach patients because governments don't consider them cost effective, the head of Europe's drugs watchdog said on Friday.

June 7, 2008

Western drug agencies need to step up cooperation to head off a repeat of the recent scandal over tainted heparin and protect patients from counterfeits, the head of the European Medicines Agency said on Friday.

June 7, 2008

Johnson & Johnson has added a strong "black box" warning about the risk of dying from cancer to the prescribing instructions for the company's Regranex diabetic foot gel, U.S. regulators said on Friday.

June 6, 2008

Wyeth will return a reformulated version of its Proheart 6 heartworm prevention drug for dogs to the U.S. market with restrictions to minimize side effects, U.S. officials and the company said on Thursday.

June 6, 2008

Doctors in Europe can continue to use Sanofi-Aventis SA's heparin medicine Lovenox, despite low levels of contamination found in some batches of the product, the European Medicines Agency said on Thursday.

June 6, 2008

U.S. regulators have broadened approval for use of Novartis AG's osteoporosis drug Reclast for prevention of new fractures in patients who have recently had a low-trauma break, the drugmaker said on Thursday.

June 6, 2008

Roche Holding AG's experimental arthritis drug Actemra will be considered for approval by a U.S. Food and Drug Administration panel on July 29.

June 5, 2008

Allergan Inc said on Wednesday it plans to apply to U.S. health regulators for marketing approval for its eyelash extender by the end of the third quarter.

June 5, 2008

AstraZeneca Plc is seeking U.S. approval to market its asthma drug Symbicort as a treatment for young children, increasing the competitive pressure on GlaxoSmithKline Plc's rival product Advair.

June 5, 2008

U.S. health officials are investigating whether drugs for rheumatoid arthritis and Crohn's disease are linked to cancers in children and young adults, the Food and Drug Administration said on Wednesday.

June 5, 2008

U.S. health officials are investigating whether TNF blockers used to treat rheumatoid arthritis and Crohn's disease are linked to cases of lymphoma and other cancers in children and young adults, the Food and Drug Administration said on Wednesday.

June 4, 2008

Lexicon Pharmaceuticals Inc said U.S. health regulators granted a speedy review for its drug to treat gastrointestinal symptoms related to certain tumors, and its shares rose 10 percent in light trade before the bell.

June 4, 2008

China's top food and drug safety official on Tuesday took personal charge of an investigation into the deaths of six patients after they were given injections from a batch of immunoglobulin, Xinhua news agency reported.

June 3, 2008

U.S. patients who use certain asthma inhalers made with ozone-depleting propellants should talk to their doctors now about alternatives ahead of a ban that starts in January, health officials said on Friday.

June 3, 2008

A new drug from Schering-Plough Corp aimed at helping patients emerge more quickly from anaesthesia has been recommended for approval in Europe, the region's medicines watchdog said on Monday.

June 3, 2008

The European Medicines Agency has recommended against approval of Takeda Pharmaceutical Co Ltd's insomnia drug Ramelteon for adults, the London-based watchdog said on Monday.

June 3, 2008

Medical device maker Abiomed Inc said U.S. health regulators approved the sale of its heart pump, Impella 2.5.

June 3, 2008

Indian drugmakerCipla Ltd has received tentative approval from the U.S. Food and Drug Administration for generic epilepsy drug topiramate tablets, the regulator's website showed.

June 3, 2008

U.S. patients who use certain asthma inhalers made with ozone-depleting propellants should talk to their doctors now about alternatives ahead of a ban that starts in January, health officials said on Friday.

June 3, 2008

The European Medicines Agency has again rejected Celgene Corp's new anaemia drug lenalidomide.

June 3, 2008

Medical device maker Abiomed Inc said U.S. health regulators approved the sale of its heart pump, Impella 2.5, driving its shares up about 24 percent to their highest in more than six years.

June 3, 2008

A new drug from Schering-Plough Corp aimed at helping patients emerge more quickly from anesthesia has been recommended for approval in Europe, the region's medicines watchdog said on Monday.

June 3, 2008

The European Medicines Agency has recommended against approval of Takeda Pharmaceutical Co Ltd's insomnia drug Ramelteon for adults, the London-based watchdog said on Monday.

May 31, 2008

The European Medicines Agency has recommended approval of cancer drug Erbitux as a first-line treatment for bowel cancer that has spread, boosting the product's sales potential in Europe.

May 31, 2008

A drug being developed by Bayer and Johnson & Johnson has again proven better than a standard treatment in preventing dangerous blood clots among patients undergoing orthopedic surgery, boosting its chances for U.S. approval.

May 31, 2008

Indian drugmakerLupin Ltd said on Friday it had got tentative approval from the U.S. Food and Drug Administration to make and market multiple strengths of topiramate tablets.

May 31, 2008

Indian drugmakerDr Reddy's Laboratories Ltd has received tentative approval from the U.S. Food and Drug Administration for omeprazole delayed-release capsules, the regulator's website showed.

May 30, 2008

GlaxoSmithKline Plc said on Thursday it had submitted its new anti-nausea drug Rezonic for approval in the United States, and presented fresh clinical data supporting the medicine's effectiveness.

May 30, 2008

Eli Lilly and Co said on Thursday a long-acting form of its schizophrenia drug Zyprexa will likely become available in the United States in the "near future," based on favorable signals from U.S. regulators.

May 30, 2008

U.S. health regulators have declined to immediately approve Wyeth's antibiotic Tygacil for treating pneumonia outside hospitals or nursing homes as they seek more data on severe cases, the drugmaker said on Thursday.

May 29, 2008

Medicines Co said U.S. health regulators declined to approve an additional dosing regimen for its anti-clotting drug Angiomax in the treatment of acute coronary syndromes, sending its shares down as much as 8 percent.

May 29, 2008

Company data for GlaxoSmithKline Plc's Promacta shows the experimental platelet-boosting drug works about as well as a placebo, a U.S. Food and Drug Administration reviewer said in documents released on Wednesday.

May 29, 2008

Switzerland's Schweizerhall said on Wednesday its blood-thinning drug clopidogrel, a copy-cat generic version of Plavix from Sanofi-Aventis and Bristol-Myers Squibb, had been approved in Germany.

May 27, 2008

Canadian biotechnology companies have joined a chorus of their global counterparts to rail against the U.S. Food and Drug Administration's tardiness in approving new drugs.

May 27, 2008

Drug maker Cadila Healthcare Ltd said on Monday its Zydus Cadila unit received the U.S. Food and Drug Administration approval to sell benazepril tablets in multiple strengths in that country.

May 27, 2008

Consumers should not buy or use Mommy's Bliss Nipple Cream, marketed by San Rafael, California-based MOM Enterprises Inc, due to ingredients that could harm infants, the U.S. Food and Drug Administration said on Friday.

May 27, 2008

Swiss drugmakerNovartis said on Monday its Extavia multiple sclerosis drug had been approved in the European Union and repeated that it planned to launch Extavia in the U.S. and Europe in the first half of 2009.

May 27, 2008

Swiss drugmaker Novartis said on Monday its Extavia multiple sclerosis drug had been approved in the European Union and repeated that it planned to launch Extavia in the U.S. and Europe in the first half of 2009.

May 24, 2008

Denmark's Novo Nordisk A/S, the world's biggest maker of insulin, has filed for regulatory approval of its experimental type 2 diabetes treatment liraglutide in the United States and Europe.

May 24, 2008

Strides Arcolab Ltd said on Friday it has got U.S. Food and Drug Administration approval for antibiotic rifampicin injection.

May 24, 2008

Tonira Pharma Ltd said on Friday it received the U.S. Food and Drug Administration approval for its drug making unit in Vadodara.

May 24, 2008

U.S. health officials on Thursday announced plans for a new computer tracking system designed to help them identify dangers from prescription drugs and medical devices already on the market.

May 24, 2008

Canadians should avoid unlicensed drugs that claim to improve sexual performance because they could cause problems such as loss of consciousness, prolonged erections and chest pain, the health ministry said on Friday.

May 24, 2008

U.S. health regulators have delayed approval of Wyeth's experimental medicine for treating osteoporosis, requesting information about blood clots and stroke, the drug maker said on Friday.

May 21, 2008

Dabur Pharma Ltd's oncology unit has received approval from the U.S. Food and Drug Administration for mitoxantrone hydrochloride injection in various strengths, according to the regulator's Website.

May 21, 2008

The U.S. Food and Drug Administration has tentatively approved Wockhardt Ltd's granisetron hydrochloride injection, according to the regulator's Website.

May 17, 2008

Shares in Arpida Ltd gained some 5 percent on Friday after the Swiss biotech company said U.S. regulators had assigned a 10-month review period to its antibiotic iclaprim. Arpida said the Food and Drug Administration had accepted its new drug application for intravenous iclaprim for treating complicated skin and skin structure infections and it had assigned a standard review period, meaning the deadline is Jan. 16, 2009.

May 17, 2008

U.S. health officials issued an alert on Friday about the risks of miscarriages and birth defects from Novartis AG and Roche Holding AG transplant drugs.

May 17, 2008

A free hotline for patients to report serious medical side effects should be mentioned in television commercials and also needs to be more widely promoted on pill bottles and pharmacy packaging, U.S. health experts said on Friday.

May 17, 2008

U.S. health officials issued an alert on Friday about the risks of miscarriages and birth defects from Novartis AGand Roche Holding AG transplant drugs.

May 16, 2008

U.S. Democratic lawmakers seeking to bolster Food and Drug Administration oversight of imported products took aim at medical devices and cosmetics on Wednesday, saying the agency lacks the money and power to properly regulate them.

May 16, 2008

Indian drugmakerRanbaxy Laboratories Ltd has received approval from the U.S. Food and Drug Administration for muscle relaxant cyclobenzaprine hydrochloride tablets, the regulator's website showed.

May 16, 2008

Cadila Healthcare Ltd said on Thursday its Zydus Cadila unit had received tentative approval from the U.S. Food and Drug Administration to sell escitalopram oxalate tablets and anastrazole tablets.

May 16, 2008

Generic drugmaker Lannett Co on Thursday said it is working with U.S. regulators to ensure a safe supply of the heart failure drug digoxin, following a recall of another version of the drug.

May 15, 2008

Strides Arcolab on Wednesday said it has got an abbreviated new drug application (ANDA) approval for flumazenil injection.

May 15, 2008

AstraZeneca said on Wednesday that U.S. regulators had approved its Seroquel medicine as a maintenance treatment for patients with bipolar disorder, as an adjunct to lithium or divalproex.

May 15, 2008

Geron Corp said U.S. health regulators placed a clinical hold on its investigational new drug submission for GRNOPC1, a cell therapy for spinal cord injury, sending its shares down 22 percent to their lowest in more than four years.

May 15, 2008

Drugmaker Aurobindo Pharma Ltd received a tentative approval from the U.S. Food and Drug Administration for its emtricitabine capsules, according to the regulator's Web site on Wednesday.

May 14, 2008

U.S. health regulators issued a warning letter to Immucor Inc, citing problems with its manufacturing practices, sending the shares of the blood-testing products maker down 5 percent.

May 12, 2008

Pipex Pharmaceuticals Inc said U.S. regulators have granted an orphan drug status for its experimental drug to idiopathic pulmonary fibrosis (IPF), a pulmonary disease.

May 12, 2008

Barr Pharmaceuticals Inc said on Friday the U.S. Food and Drug Administration has approved the sale of its generic version of the oral contraceptive Yasmin.

May 12, 2008

Drug firm Aurobindo Pharma Ltd said on Monday it got approval from Medicines Control Council to manufacture and market nine products in South Africa.

May 9, 2008

Denmark's Novo Nordisk won U.S. approval to sell a new formulation of a genetically engineered version of Factor VIIa, regulators said on Friday.

May 9, 2008

Denmark's Novo Nordisk won U.S. approval to sell a new formulation of a genetically engineered protein therapy that helps the blood clot, regulators said on Friday.

May 8, 2008

Pharmaceutical companies need to be more responsible in touting their products to consumers or else face tighter controls from Congress, a top U.S. Democratic lawmaker said on Thursday.

May 8, 2008

A panel of expert advisers to the U.S. Food and Drug Administration will meet at the end of this month to review GlaxoSmithKline Plc's experimental drug for treating a disorder in which the blood does not clot properly, according to Amgen Inc.

May 8, 2008

Medtronic Inc said on Wednesday it was voluntarily recalling some disposable devices used during cardiac bypass surgery because they have been found to be coated with contaminated traces of the blood-thinner heparin.

May 8, 2008

The U.S. Food and Drug Administration told ZymoGenetics Inc that promotional material for its Recothrom product, used to help control bleeding, was false or misleading, according to a letter released on Wednesday.

May 8, 2008

Spain's Zeltia said on Thursday its cancer drug Yondelis has been approved for sale in South Korea, pushing shares higher.

May 8, 2008

A U.S. advocacy group is urging the Food and Drug Administration to pull Johnson & Johnson's birth control patch from the market after studies found an increased risk of dangerous blood clots.

May 8, 2008

AstraZeneca Plc said on Thursday it had applied to U.S. regulators to sell its schizophrenia drug Seroquel XR as a treatment for anxiety.

May 8, 2008

Indian drug maker FDC Ltd has received the U.S. Food and Drug Administration approval for its timolol maleate eye solution, the regulator's Web site showed on Wednesday.

May 8, 2008

The U.S. Food and Drug Administration has approved Cadila Healthcare Ltd's cholesterol-fighter pravastatin sodium tablets in various strengths, the regulator's Web site showed on Wednesday.

May 8, 2008

The U.S. Food and Drug Administration told ZymoGenetics Inc that promotional material for its Recothrom product, used to help control bleeding, was false or misleading, according to a letter released on Wednesday.

May 8, 2008

Japan's Astellas Pharma said on Wednesday it would suffer further delays in approval for a new version of its key transplant drug after U.S. authorities said they were not ready to approve it for liver transplants.

May 8, 2008

A U.S. advisory panel recommended approval on Wednesday for a proposed sedative from Japan's Eisai Co Ltd but urged against use by health-care workers without general anesthesia training.

May 7, 2008

Cardinal Health Inc said on Monday it is recalling 60,000 bottles of alcohol-free mouthwash from nearly 1,000 U.S. hospitals that was tested and found positive for a bacteria called Burkholderia cepacia.

May 7, 2008

Chinese officials said on Tuesday a Chinese-made blood thinner was not to blame for fatalities linked to the product, and accused U.S. drugmakerBaxter International Inc of obstructing the investigation into the cause of the problem.

May 7, 2008

Medical equipment maker Opto Circuits India Ltd said on Tuesday its unit has received marketing approval from the U.S. Food and Drug Administration for two vital signs monitoring systems.

May 6, 2008

General Electric Co said on Monday the U.S. Food and Drug Administration (FDA) had given it permission to resume shipping X-ray machines made at its Salt Lake City, Utah plant.

May 3, 2008

AstraZeneca Plc said on Friday it had applied to sell its lung cancer drug Iressa in Europe as a treatment for selected patients.

May 2, 2008

Allowing Cephalon Inc to market its Fentora pain drug more widely for patients without cancer could have "devastating effects," a U.S. Food and Drug Administration official said in documents released on Friday.

May 2, 2008

The U.S. Food and Drug Administration declined to immediately approve Discovery Laboratories Inc's drug to help prevent respiratory distress syndrome in premature babies, the company said on Friday, sending shares down 41 percent.

May 1, 2008

U.S. health regulators have said GlaxoSmithKline Plc's Advair is safe and effective to more widely treat patients with chronic obstructive pulmonary disease (COPD), the drugmaker said on Wednesday.

May 1, 2008

U.S. health regulators have said GlaxoSmithKline Plc's Advair is safe and effective to more widely treat patients with chronic obstructive pulmonary disease (COPD), the drugmaker said on Wednesday.

May 1, 2008

The U.S. Food and Drug Administration aims to hire more than 1,300 biologists, chemists, pharmacologists and other staff members by October as part of a major expansion, the agency said on Wednesday.

April 30, 2008

U.S. regulators have warned Merck & Co Inc about manufacturing deficiencies related to vaccine production at a company plant in West Point, Pennsylvania, according to a letter released on Wednesday.

April 30, 2008

The U.S. Food and Drug Administration aims to hire more than 1,300 biologists, chemists, pharmacologists and other staff members by October as part of a major expansion, the agency said on Wednesday.

April 30, 2008

The Food and Drug Administration on Tuesday approved the first U.S. drug to treat irritable bowel syndrome with constipation (IBS-C) in adult women.

April 30, 2008

The Food and Drug Administration on Tuesday approved the first U.S. drug to treat irritable bowel syndrome with constipation (IBS-C) in adult women, a medicine marketed by Takeda Pharmaceutical Co and its developer, Sucampo Pharmaceuticals Inc.

April 30, 2008

AstraZeneca Plc is seeking U.S. approval to sell its asthma drug Symbicort for chronic obstructive pulmonary disease (COPD), ramping up competition with GlaxoSmithKline Plc's Advair.

April 29, 2008

U.S. health regulators have rejected Merck & Co Inc's new drug designed to raise the level of HDL cholesterol, the company said on Monday.

April 29, 2008

A unit of Medtronic Inc has reached agreement on a consent decree with the U.S. Food and Drug Administration about quality system improvements for its external defibrillators, the manufacturer said Monday.

April 29, 2008

Watson Pharmaceuticals Inc said on Tuesday the U.S. Food and Drug Administration completed an inspection at a Florida manufacturing plant, potentially clearing the way for approvals of generic drugs made at the site, sending the company's shares up more than 7 percent.

April 29, 2008

People who lost relatives to deadly reactions from the blood-thinner heparin are set to testify on Tuesday before U.S. lawmakers probing contamination of the drug made with raw ingredients imported from China.

April 29, 2008

U.S. health regulators have rejected Merck & Co Inc's new drug designed to raise the level of HDL, or "good" cholesterol, the company said on Monday, sending its shares down 5 percent.

April 29, 2008

Drugmakers Schering-Plough Corp and Merck & Co said on Friday the U.S. Food and Drug Administration rejected a proposed asthma-allergy drug that would have combined two best-selling drugs, Claritin and Singulair, into one tablet.

April 29, 2008

A unit of Medtronic Inc has reached agreement on a consent decree with the U.S. Food and Drug Administration about quality system improvements for its external defibrillators, the manufacturer said on Monday.

April 29, 2008

A unit of Medtronic Inc has reached agreement on a consent decree with the U.S. Food and Drug Administration about quality system improvements for its automatic external defibrillators, the manufacturer said on Monday.

April 26, 2008

Wyeth and Progenics Pharmaceuticals Inc won U.S. approval to sell a new drug to relieve the constipation that often occurs with use of morphine or other opioid painkillers, regulators said on Thursday.

April 26, 2008

Isis Pharmaceuticals Inc said U.S. health regulators have asked for data from two preclinical carcinogenic studies of its cholesterol drug, mipomersen, to be included in the final late-stage study results, sending its shares tumbling 30 percent.

April 26, 2008

Belgian pharmaceutical group UCB SA said it had won sooner than expected approval for its Neupro restless legs syndrome (RLS) drug by the Committee for Medicinal Products for Human Use (CHMP).

April 26, 2008

Indian drug maker Ranbaxy Laboratories Ltd said on Friday it had received approval from the U.S. Food and Drug Administration for cetirizine hydrochloride oral solution.

April 26, 2008

The European Medicines Agency has recommended approval of MediGene's skin drug Oracea to treat rosacea that causes pimple-like blemishes and redness on the face, MediGene said on Friday.

April 25, 2008

Batches of Sanofi-Aventis's blood-thinning heparin injection Lovenox have been found to contain small amounts of impurity in Britain, Sweden, Spain and Australia, officials said on Thursday.

April 25, 2008

Roche Holding AG will appeal over a British decision against approving its Tarceva as a cost effective treatment for lung cancer, the Swiss drugmaker said on Thursday.

April 25, 2008

U.S. regulators approved Biovail Corp's Aplenzin extended-release tablets for treating depression, a Food and Drug Administration spokeswoman said on Wednesday.

April 25, 2008

Belgian pharmaceutical group UCB said on Thursday it had little doubt that its Cimzia drug would be cleared by European authorities to treat bowel disorder Crohn's disease.

April 25, 2008

Strides Arcolab Ltd said on Thursday the U.S. Food and Drug Administration had approved two of its ondansetron injections.

April 25, 2008

Wyeth Pharmaceuticals, a unit of Wyeth said on Wednesday it was withdrawing an application for European approval to use the antibiotic Tygacil for community-acquired pneumonia (CAP).

April 25, 2008

The European Medicines Agency has recommended approval of CV Therapeutic's Latixa to treat chronic chest pain, or angina, giving the biotech company access to a potential market bigger than that in the United States.

April 25, 2008

European drug regulators on Thursday recommended approval of GlaxoSmithKline Plc's new breast cancer pill Tykerb, or Tyverb, but with additional warnings about potential liver toxicity.

April 23, 2008

Alpharma Inc said it will withdraw the application seeking approval for its painkiller, Embeda, due to certain issues that prevented a complete evaluation by U.S. health regulators in the allotted time.

April 23, 2008

U.S. health officials approved Belgian drugmaker UCB Inc's experimental drug to treat Crohn's disease but warned about serious side effects, the U.S. Food and Drug Administration said on Tuesday.

April 23, 2008

Lax U.S. oversight of drug ingredient makers in China and other countries is putting Americans at risk of exposure to more dangerous medicines like the tainted blood-thinner heparin, lawmakers said on Tuesday.

April 23, 2008

The laser eye surgery industry is steeling itself ahead of a Friday meeting expected to draw complaints from patients with blurred vision and other complications of a popular vision procedure.

April 23, 2008

U.S. health officials approved Belgian drugmaker UCB Inc's experimental drug Cimzia to treat adults with moderate to severe Crohn's disease that has not responded to conventional treatment, but warned about serious side effects, the U.S. Food and Drug Administration said on Tuesday.

April 22, 2008

U.S. Food and Drug Administration officials warned Baxter International Inc's supplier of the blood thinner heparin for failing to ensure that its manufacturing process can remove impurities, according to a letter released on Monday.

April 22, 2008

Thalidomide, which caused birth defects when it was launched as a morning sickness pill half a century ago, has been officially approved in the European Union as a treatment for multiple myeloma.

April 22, 2008

APP Pharmaceuticals Inc said it received approval from U.S. health regulators for a generic version of JHP Pharmaceuticals' Coly-Mycin M Parenteral to treat infections caused by certain bacteria.

April 22, 2008

Chinese investigators have concluded that a contaminant found in the blood-thinner heparin was not the cause of deaths and allergic reactions related to the drug in the United States, Chinese health officials said on Monday.

April 18, 2008

Angiotech Pharmaceuticals said on Thursday that the U.S. Food and Drug Administration approved the marketing of its drug-eluting Central Venous Catheter in the United States.

April 17, 2008

A cheaper, generic version of GlaxoSmithKline Plc's Wellbutrin XL antidepressant is just as safe and effective, despite complaints from some patients, the Food and Drug Administration said Wednesday.

April 17, 2008

A cheaper, generic version of GlaxoSmithKline Plc's Wellbutrin XL antidepressant is just as safe and effective, despite complaints from some patients, the Food and Drug Administration said Wednesday.

April 17, 2008

Shares of Pozen Inc soared more than 40 percent on Wednesday after U.S. health regulators finally approved the combination migraine treatment it developed with GlaxoSmithKline Plc.

April 17, 2008

Swiss drug maker Roche said on Wednesday its Actemra drug was approved in Japan for treating rheumatoid arthritis, the drug's first approval for a major disease.

April 17, 2008

Alcon Inc said on Tuesday that U.S. regulators approved its Patanase allergy nasal spray.

April 17, 2008

Swiss drug maker Roche said on Wednesday its Actemra drug was approved in Japan for treating rheumatoid arthritis, the drug's first approval for a major disease.

April 17, 2008

The U.S. Food and Drug Administration has approved a combination migraine drug from GlaxoSmithKline Plc and Pozen Inc, the companies said on Tuesday.

April 17, 2008

The U.S. Food and Drug Administration has approved a combination migraine drug from GlaxoSmithKline Plc and Pozen Inc, the companies said on Tuesday.

April 16, 2008

The U.S. Food and Drug Administration does not have the funding it needs to adequately protect the nation's increasingly global supply of food and drugs, a bipartisan Senate panel said on Tuesday.

April 16, 2008

The contamination of Baxter International Inc's recalled heparin likely was done for economic reasons, the head of the U.S. Food and Drug Administration said on Tuesday.

April 16, 2008

Paladin Labs Inc's Plan B morning-after contraceptive pill is a step closer to winning full over-the-counter status in Canada, the drug maker said on Monday.

April 16, 2008

The contamination of Baxter International Inc's recalled blood thinner heparin likely was done for economic reasons, the head of the U.S. Food and Drug Administration said on Tuesday.

April 12, 2008

Drug makers CV Therapeutics and Astellas Pharma Inc said on Friday the U.S. Food and Drug Administration (FDA) had approved their heart-imaging agent regadenoson, also called Lexiscan.

April 12, 2008

Canadian pharmaceutical company PreMD Inc said on Friday that the U.S. Food and Drug Administration has upheld its decision not to approve expanded use for the company's skin cholesterol test.

April 12, 2008

Canadian pharmaceutical company PreMD Inc said on Friday that the U.S. Food and Drug Administration has upheld its decision not to approve expanded use for the company's skin cholesterol test.

April 12, 2008

Drug makers CV Therapeutics and Astellas Pharma Inc said on Friday the U.S. Food and Drug Administration (FDA) had approved their heart-imaging agent regadenoson, also called Lexiscan.

April 11, 2008

Cubist Pharmaceuticals Inc is warning doctors that a chemical used in manufacturing rubber has been found in some of its Cubicin injectable antibiotic stored in pumps made by Cardinal Health Inc, U.S. health regulators said on Wednesday.

April 11, 2008

U.S. health regulators are investigating whether two transplant drugs made by Switzerland's Roche Holding AG and Novartis AG could be linked to a rare central nervous system disorder, the U.S. Food and Drug Administration said on Thursday.

April 10, 2008

Labopharm Inc's lengthy struggle to get U.S. Food and Drug Administration approval for its once-daily version of the pain killer tramadol could be over in about four months, its president and chief executive, James Howard-Tripp, told Reuters on Tuesday.

April 10, 2008

U.S. regulators said Tuesday they now have 62 reports of patients given heparin who died in the past 15 months following symptoms of allergic reactions or low blood pressure.

April 10, 2008

Cubist Pharmaceuticals Inc is warning doctors that a chemical used in manufacturing rubber has been found in some of its Cubicin injectable antibiotic stored in pumps made by Cardinal Health Inc, U.S. health regulators said on Wednesday.

April 10, 2008

Cubist Pharmaceuticals Inc is warning doctors that a chemical used in manufacturing rubber has been found in some of its Cubicin injectable antibiotic stored in pumps made by Cardinal Health Inc, U.S. health regulators said on Wednesday.

April 10, 2008

Amgen Inc said on Tuesday that U.S. health regulators have delayed by three months a decision on whether to approve its drug, romiplostim, for treatment of a disorder in which the blood does not clot properly.

April 10, 2008

U.S. regulators said Tuesday they now have 62 reports of heparin patients who died in the past 15 months following symptoms of allergic reactions or low blood pressure.

April 6, 2008

Watson Pharmaceuticals has recalled one lot, or about 28,000 units, of its fentanyl pain patch after ingredient levels were found to have deviated from specifications, a company spokeswoman said on Friday.

April 6, 2008

A second oral rotavirus vaccine, GlaxoSmithKline's Rotarix, for preventing severe diarrhea in infants won approval from U.S. health officials on Thursday.

April 6, 2008

A second oral vaccine to prevent a leading cause of severe diarrhea in infants won approval from U.S. health officials on Thursday.

April 6, 2008

Watson Pharmaceuticals has recalled one lot, or about 28,000 units, of its fentanyl pain patch after ingredient levels were found to have deviated from specifications, a company spokeswoman said on Friday.

February 28, 2008

The U.S. Food and Drug Administration is examining the way it tells the public about safety concerns with foods, prescription drugs, medical devices and other products it regulates, the agency's commissioner said Thursday.

February 28, 2008

U.S. regulators have rejected a long-acting injectable form of Zyprexa, also known by the generic name olanzapine, an antipsychotic used to treat schizophrenia and bipolar disorder, Eli Lilly and Co said on Thursday.

February 28, 2008

U.S. regulators have rejected a long-acting injectable form of Eli Lilly and Co's blockbuster schizophrenia drug Zyprexa, the company said on Thursday, sending its shares down 2 percent.

February 28, 2008

AstraZeneca Plc's Nexium drug has been approved in the United States for treating excess stomach acid in children aged 1 to 11, the Food and Drug Administration (FDA) said on Thursday.

February 28, 2008

Novartis will seek regulatory clearance for kidney cancer drug Everolimus in the second half of 2008 after it cleared late-stage testing earlier than expected, the Swiss drugmaker said on Thursday.

February 28, 2008

Pfizer Inc said on Thursday that six of its drugs could be approved in Japan this year, including the cancer drug Sutent.

February 28, 2008

Sun Pharmaceutical Industries Ltd has received approval from the U.S. Food and Drug Administration for torsemide tablets in multiple strengths, the Indian drug maker said.

February 27, 2008

Healthcare products company Covidien said on Wednesday the U.S. Food and Drug Administration granted tentative approval for its generic imaging agent used for detecting coronary artery disease.

February 27, 2008

Health Canada lifted its warning on Wednesday on two AstraZenecadrugs used to treat acid-related stomach disorders after it determined there was no obvious link between the treatments and heart attacks and cardiac deaths.

February 27, 2008

The U.S. Food and Drug Administration is launching a new effort meant to strengthen its oversight of prescription drugs after they win approval, an agency official said on Tuesday.

February 26, 2008

Swiss-Swedish dental implant maker Nobel Biocare said on Tuesday it has been cleared to sell its NobelDirect and NobelPerfect implant products following a review by a medical agency.

February 25, 2008

GTx Inc's experimental drug for treating fractures and other side effects of a commonly used prostate cancer treatment has the potential to reach $200 million to $400 million in annual U.S. sales, the company's chief executive said on Monday.

February 25, 2008

The U.S. Food and Drug Administration said on Monday it canceled Wednesday's advisory panel review of an experimental Theravance Inc antibiotic to allow time for the agency to resolve "several outstanding issues."

February 25, 2008

Boston Scientific Corp on Monday said U.S. regulators approved three products in its cardiac rhythm management business.

February 25, 2008

The European Union approved Novartis's Eucreas diabetes pill, the Swiss drugmaker said on Monday, following its approval of Galvus, one of the two-in-one drug's ingredients.

February 25, 2008

The U.S. Food and Drug Administration's unexpected approval of Genentech Inc's drug, Avastin, to fight breast cancer may represent an incremental evolution in the way the FDA reviews cancer drugs, a top agency official said on Friday.

February 25, 2008

The European Union approved Novartis's Eucreas oral treatment for diabetes, the Swiss drugmaker said on Monday, following its approval of Galvus (vildagliptin), one of the two-in-one drug's ingredients.

February 25, 2008

Swiss biotechnology company Actelion has withdrawn its application for approval for a new use of its Zavesca drug, the European Medicines Agency said on Monday.

February 25, 2008

Analysts raised forecasts for Roche Holding AG on Monday after U.S. regulators approved its Avastin drug for treating advanced breast cancer, adding a potentially significant new revenue source.

February 22, 2008

Eli Lilly and Co on Friday said an advisory panel to European regulators has recommended that its Alimta (pemetrexed) be approved for the new use as a first-line treatment for advanced lung cancer.

February 22, 2008

Abbott Laboratories Inc on Friday said U.S. regulators approved use of its blockbuster arthritis drug Humira to treat the new indication of juvenile rheumatoid arthritis.

February 22, 2008

Eli Lilly and Co on Friday said an advisory panel to European regulators has recommended that its Alimta drug be approved for the new use as a first-line treatment for advanced lung cancer.

February 22, 2008

Abbott Laboratories Inc on Friday said U.S. regulators approved use of its arthritis drug Humira (adalimumab) to treat the new indication of juvenile rheumatoid arthritis.

February 22, 2008

U.S. regulators have granted priority review to a closely watched drug for preventing blood clots being developed by Eli Lilly and Co and Daiichi Sankyo, the companies said Thursday.

February 22, 2008

Two U.S. House of Representatives Democrats asked Baxter International Inc on Thursday to provide records about the manufacturing of its blood-thinning drug, heparin, as well as recent reports of serious reactions.

February 21, 2008

The European Medicines Agency has recommended approval of four biosimilar versions of Neupogen, Amgen's best-selling treatment for neutropenia, marking a further opening of the biotech drug market to generic copies.

February 20, 2008

GlaxoSmithKline Plc's infant vaccine to prevent diarrhea caused by the rotavirus appears safe and effective, based on available data, U.S. advisers said on Wednesday.

February 20, 2008

GlaxoSmithKline Plc's (GSK.L: Quote, Profile, Research) infant vaccine to prevent diarrhea caused by the rotavirus appears safe and effective, based on available data, U.S. advisers said on Wednesday.

February 20, 2008

Orchid Chemicals & Pharmaceuticals Ltd said on Wedsnesday it received the U.S. Food and Drug Administration's marketing approval for its cefuroxime axetil tablets in multiple strengths.

February 19, 2008

Chelsea Therapeutics International Ltd said it reached an agreement with the U.S. Food and Drug Administration regarding the design of a late-stage trial of its drug Droxidopa, used for treating a neurological disorder that can cause drops in blood pressure.

February 19, 2008

Marshall Edwards Inc said its experimental cancer drug triphendiol was granted an orphan drug status by the U.S. Food and Drug Administration for treatment of malignant melanoma.

February 19, 2008

French drug group Sanofi-Aventis and Belgium's UCB said on Tuesday that the Food and Drug Administration (FDA) approved a New Drug Application (NDA) for Xyzal (levocetirizine dihydrochloride) 0.5 mg/mL oral solution.

February 18, 2008

Abbott Laboratories Inc on Friday said U.S. regulators have approved its Simcor pill, the company's newest combination product to treat cholesterol.

February 18, 2008

Abbott Laboratories Inc on Friday said U.S. regulators have approved its Simcor pill, the company's newest combination product to treat cholesterol.

February 15, 2008

Rotarix, GlaxoSmithKline Plc's investigational rotavirus vaccine, is associated with increased pneumonia-related deaths and other adverse reactions, U.S. regulatory staff said in documents posted on Friday.

February 15, 2008

Health regulators on Friday issued draft guidance that would make it easier for pharmaceutical companies to advise doctors about unapproved uses for their medicines.

February 15, 2008

The lives of 22,000 patients could have been saved if U.S. regulators had been quicker to remove a Bayer AG drug used to stem bleeding during open heart surgery, according to a medical researcher interviewed by CBS Television's 60 Minutes program.

February 15, 2008

GlaxoSmithKline Plc's rotavirus vaccine is associated with increased pneumonia-related deaths and other adverse reactions, U.S. regulatory staff said in documents posted on Friday.

February 14, 2008

Drugmaker Orchid Chemicals & Pharmaceuticals Ltd said on Thursday it has secured the U.S. Food and Drug Administration approval to sell generic version of nausea treatment granisetron hydrochloride tablets. (Reporting by Bharghavi Nagaraju, editing by Harish Nambiar)

February 14, 2008

Sun Pharmaceuticals Industries Ltd, India's top drug maker by market value, said on Thursday it had received tentative approval from the U.S. Food and Drug Administration for a generic version of Depakote tablets.

February 14, 2008

U.S. regulators have never inspected the Chinese plant that makes Baxter International's heparin, regulators disclosed a day after Baxter halted sales of some versions after four patients died and hundreds became ill.

February 12, 2008

Drugmaker Perrigo Co said the U.S. Food and Drug Administration granted final approval to market a generic version of Pepcid, the antacid produced by Johnson & Johnson and Merck Consumer Pharmaceutical.

February 12, 2008

Drug maker Wockhardt Ltd said on Tueday it received the U.S. Food and Drug Administration's approval to sell antibiotic azithromycin tablets in various strengths.

February 12, 2008

Natus Medical Inc said it is now cleared by U.S. health regulators to resume shipping the Cool Cap device, used to cool the head in newborns, within the United States.

February 11, 2008

Hi-Tech Pharmacal Co Inc said it received approval from the U.S. Food and Drug Administration for its generic version of Endo Pharmaceuticals Holdings Inc's cough drug, Hycodan.

February 11, 2008

Biopharmaceutical company CytRx Corp said the U.S. Food and Drug Administration needs more data from an animal toxicology study to let the firm's trial of a treatment of Lou Gehrig's disease progress.

February 8, 2008

U.S. regulators said on Friday they were reviewing the safety of Allergan Inc's Botox and a competing product, after reports of deaths and serious reactions in some patients.

February 8, 2008

U.S. regulators said on Friday they were reviewing the safety of Allergan Inc's Botox and a competing product after reports of deaths and serious reactions in some patients.

February 8, 2008

APP Pharmaceuticals Inc said it received approval from the U.S. Food and Drug Administration for its generic version of Bristol-Myers Squibb Co's cancer drug Blenoxane.

February 8, 2008

APP Pharmaceuticals Inc said it received approval from the U.S. Food and Drug Administration for its generic version of Bristol-Myers Squibb Co's cancer drug Blenoxane.

February 8, 2008

Labopharm Inc's shares jumped more than 20 percent on Friday after the company said its phase 3 trials for its once-daily formulation of the antidepressant trazodone showed that the treatment hit its key endpoints.

February 7, 2008

A U.S. advisory panel on Wednesday backed Eli Lilly and Co's proposed long-acting form of schizophrenia drug Zyprexa.

February 7, 2008

U.S. regulators said on Thursday they approved a novel type of heart valve made by CryoLife Inc, composed of human tissue with cells removed to potentially lower the risk of rejection.

February 7, 2008

Dental laser company Biolase Technology Inc said it received marketing approval from U.S. health regulators for its Waterlase MD Laser System for use in dermatological applications as well as general and plastic surgery.

February 7, 2008

India's Ranbaxy Laboratories Ltd has tentative U.S. approval to sell a generic form of AstraZeneca Plc's blockbuster heartburn and ulcer pill Nexium, damaging confidence in the Anglo-Swedish drugmaker's future profits.

February 7, 2008

GlaxoSmithKline Plc will update the U.S. Food and Drug Administration on its cervical cancer vaccine Cervarix by the third quarter of 2008, its chief executive said on Thursday.

February 6, 2008

Medtronic Inc. said on Wednesday that it had won U.S. regulatory approval for its implantable neurostimulation device to treat chronic back and leg pain.

February 6, 2008

Medtronic Inc. said on Wednesday that it had won U.S. regulatory approval for its implantable neurostimulation device to treat chronic back and leg pain.

February 6, 2008

The United States is hoping bolster the safety of food and other products imported from China by opening a new Food and Drug Administration office in the Asian nation.

February 6, 2008

An approval path for generic versions of expensive biotechnology medicines should give regulators flexibility to determine testing requirements and protect innovation by brand-name makers, the head of the Food and Drug Administration said Tuesday.

February 6, 2008

Indian drugmakerRanbaxy Laboratories Ltd said on Wednesday it had received approval from the U.S. Food and Drug Administration to make and market cefuroxime axetil in the oral suspension form.

February 5, 2008

An approval path for generic versions of expensive biotechnology medicines should give regulators flexibility to determine testing requirements and protect innovation by brand-name makers, the head of the U.S. Food and Drug Administration said on Tuesday.

February 5, 2008

St. Jude Medical Inc said integrated irrigation pump and cardiac ablation generator, components developed for use with its irrigated catheters, received the CE mark of European regulatory approval.

February 5, 2008

Drug maker Aurobindo Pharma Ltd has received the U.S. Food and Drug Administration approval for its fluoxetine hydrochloride and gabapentin capsules in multiple strength, the regulator's Web site showed on Tuesday.

February 4, 2008

New funds for the Food and Drug Administration to speed review of generic pharmaceuticals and new authority to approve copycat versions of biotech drugs were proposed in President George W. Bush's budget on Monday.

February 4, 2008

Excessive sedation is a "serious safety concern" with an experimental, long-acting form of Eli Lilly and Co's Zyprexa (olanzapine) schizophrenia drug, U.S. drug reviewers said in an analysis released on Monday.

February 4, 2008

The European Commission has approved Roche Holding AG's oral chemotherapy Xeloda (capecitabine) for treating metastatic colorectal cancer, the Swiss company said on Monday.

February 4, 2008

Schering-Plough Corp said U.S. health regulators approved Asmanex twisthaler for treatment of asthma in children aged between 4 and 11.

February 4, 2008

The European Commission has approved Roche Holding AG's oral chemotherapy Xeloda for treating metastatic colorectal cancer, the Swiss company said on Monday.

February 4, 2008

Excessive sedation is a serious concern following injections of a long-acting form of Eli Lilly and Co's Zyprexa schizophrenia medicine, U.S. drug reviewers said in an analysis released on Monday.

February 4, 2008

Shares in Swiss healthcare provider Galenica jumped 15 percent on Monday after a U.S. Food and Drug Administration advisory panel surprised investors by backing its Ferinject anaemia drug.

February 4, 2008

A U.S. advisory panel on Friday voted against recommending broad use of a Daiichi Sankyo injectable anemia drug but backed the treatment for some women.

February 4, 2008

IDM Pharma Inc's drug for the treatment of a rare bone cancer got a fresh lease of life after European health authorities gave the company more time to respond to its questions on the drug, sending the stock up 42 percent.

February 4, 2008

Akela Pharma Inc said on Monday it received a letter from the U.S. Food and Drug Administration saying that its six-month inhalation toxicology studies for its lead product were deemed invalid due to GLP (Good Laboratory Practice) deviations.

February 4, 2008

Schering-Plough Corp said U.S. health regulators approved Asmanex twisthaler for treatment of asthma in children aged between 4 and 11.

February 1, 2008

U.S. regulators on Friday said Pfizer Inc's anti-smoking drug Chantix (varenicline) appears increasingly likely to be linked to serious psychiatric behavior, and called for stronger label warnings.

February 1, 2008

U.S. regulators on Friday said Pfizer Inc's anti-smoking drug Chantix appears increasingly likely to be linked to serious psychiatric behavior, and called for stronger label warnings.

February 1, 2008

U.S. health regulators on Friday approved Medtronic Inc's new drug-eluting heart stent, the first heart device of its kind to win U.S. approval in about 4 years.

February 1, 2008

Drug maker Aurobindo Pharma Ltd said on Friday it received tentative approval from the U.S. Food and Drug Administration for its sumatriptan succinate tablets, used to treat acute migraine.

February 1, 2008

The U.S. Food and Drug Administration has approved the sale of Wockhardt Ltd's extended phenytoin sodium capsule in that country, the agency's website showed on Friday.

February 1, 2008

European authorities have approved Novartis's drug Galvus as a new oral treatment for type 2 diabetes patients, paving the way for launches in Europe, the Swiss company said on Friday.

February 1, 2008

European authorities have approved Novartis's drug Galvus (vildagliptin), a DPP-4 inhibitor, as a new oral treatment for type 2 diabetes patients, the Swiss company said on Friday.

January 31, 2008

Teva Pharmaceutical Industries Ltd said the U.S. health regulators granted a tentative approval to its generic equivalent of Boehringer Ingelheim's Flomax capsules for the treatment of signs and symptoms of an enlarged prostate.

January 31, 2008

U.S. health officials alerted doctors on Thursday that medicines used to treat epilepsy and psychiatric disorders may raise the risk of suicidal thoughts and behavior.

January 31, 2008

Schering-Plough Corp said the U.S. Food and Drug Administration has granted priority review status to Peginterferon Alfa-2b, an adjuvant treatment for a rare skin cancer, melanoma.

January 31, 2008

U.S. health officials alerted doctors on Thursday that antiepileptic medications may raise the risk of suicidal thoughts and behavior.

January 31, 2008

Cheap generic versions of more expensive branded drugs are not getting to doctors and patients as rapidly as they should because of delays at regulatory agencies, Europe's generics industry said on Thursday.

January 31, 2008

French drugs firm Ipsen said on Thursday that the Food and Drug Administration (FDA) had accepted the filing of its biologic licence application (BLA) for Dysport in the United States to treat patients with cervical dystonia.

January 31, 2008

GlaxoSmithKline Plc, the world's second-biggest drugmaker, said on Thursday its experimental childhood vaccine Synflorix to prevent pneumococcal disease had been accepted for review by European authorities.

January 31, 2008

U.S. health regulators have refused to accept Medicis Pharmaceutical Corp's application for a rival to the popular Botox anti-wrinkle drug because the application lacked enough information, the company said on Thursday.

January 30, 2008

Shares in Swiss healthcare provider Galenica closed 17 percent down after a study by the U.S. Federal Drugs Administration (FDA) raised safety concerns about the firm's iron-replacement treatment.

January 30, 2008

Merck & Co said on Tuesday that U.S. health regulators approved a new intravenous form of its anti-nausea drug Emend for patients undergoing chemotherapy.

January 30, 2008

U.S. health regulators are fending off criticism of a lax response to major drug safety controversies by warning the public earlier about potential risks, but the practice is giving many heartburn.

January 30, 2008

U.S. regulators warned Novartis AG that a German plant has produced contaminated vaccines, and it has failed to track down the source of the problems, a letter released on Tuesday said.

January 30, 2008

The U.S. Food and Drug Administration fails to inspect domestic plants that produce pacemakers and other high-risk medical devices as often as required and checks few manufacturing sites overseas, congressional investigators told Congress on Tuesday.

January 30, 2008

U.S. regulators will review on a priority basis Millennium Pharmaceuticals Inc's Velcade as a treatment for patients with newly diagnosed multiple myeloma, the company said on Wednesday.

January 30, 2008

Pharmaceutical company Akorn Inc said the U.S. Food and Drug Administration approved its generic version of a drug to manage hypocalcemia -- low levels of calcium in the blood -- in patients undergoing chronic kidney dialysis.

January 29, 2008

Escalon Medical Corp said it received marketing clearance from the U.S. health regulators for its VascuView Visual Ultrasound System for use with assisted vascular access.

January 29, 2008

Medtronic Inc said U.S. health regulators approved its blood sugar monitoring device, the CGMS iPro Recorder.

January 29, 2008

NPS Pharmaceuticals Inc said U.S. health regulators recommended the company conduct a confirmatory late-stage study prior to submitting a new drug application for Gattex, its drug for short bowel syndrome.

January 29, 2008

Dutch biotechnology firm Pharming said on Tuesday it will again seek approval for its key medicine Rhucin at the European Medicines Agency (EMEA) by Feb. 11 at the latest, sending its shares up.

January 29, 2008

Pipex Pharmaceuticals Inc said U.S. health regulators denied further review of a marketing application for its drug, Coprexa, treating a neurologic disorder called Wilson's Disease, pending a safety study, among other demands.

January 28, 2008

Nine lots of heparin blood thinner -- the medicine at the center of a lawsuit filed by actor Dennis Quaid over an overdose given to his newborn twins -- were recalled by Baxter International Inc after an increase in reports of adverse reactions in patients.

January 28, 2008

U.S. regulators have rejected Merck & Co Inc's bid to sell its Mevacor cholesterol-lowering drug without a prescription, the company said on Friday.

January 28, 2008

Nine lots of heparin blood thinner -- the medicine at the center of a lawsuit filed by actor Dennis Quaid over an overdose given to his newborn twins -- were recalled by Baxter International Inc after an increase in reports of adverse reactions in patients.

January 28, 2008

German drug maker Bayer AG said on Monday its drug Nexavar had been approved in Japan for the treatment of advanced kidney cancer, beating rival makers of similar therapies to the market here.

January 28, 2008

Drug maker Glenmark Pharmaceuticals Ltd said on Monday it received approval from the U.S. Food and Drug Administration to sell ointments and creams made at its unit in Baddi, Himachal Pradesh in the U.S.

January 28, 2008

Swiss drugmaker Roche's key cancer drug Avastin has received approval for wider use in the European Union, the company said on Monday.

January 28, 2008

British drugmaker GlaxoSmithKline and U.S.-based Synta Pharmaceuticals Corp said U.S. health regulators granted orphan drug status to the companies' drug elesclomol to treat a rare skin cancer, melanoma.

January 25, 2008

Cephalon Inc said U.S. health regulators accepted its application for the use of its painkiller, Fentora, for breakthrough pain in opioid-tolerant patients with chronic pain.

January 25, 2008

regulators said Friday they would review whether to take action over Merck & Co Inc's and Schering-Plough Corp's popular cholesterol medicine Vytorin after a study showed it was no better than a generic drug in preventing the build-up of fatty plaque.

January 25, 2008

The U.S. Food and Drug Administration scheduled a briefing for Friday afternoon to discuss an "early communication" about the Merck & Co Inc and Schering-Plough cholesterol drug Vytorin.

January 25, 2008

For patients weary of scary headlines about popular treatments like the heart drug Vytorin, a new report issued on Thursday by the U.S. Institute of Medicine may offer welcome relief.

January 25, 2008

Johnson & Johnson's Cordis unit recalled its Fire Star-RX and Dura Star-RX PTCA balloon catheters used in angioplasty after it was determined they could cause serious injury or death, according to a notice posted on the U.S. Food and Drug Administration's Web site on Friday.

January 25, 2008

Europe's drug watchdog on Thursday recommended Cephalon's drug Effentora to treat breakthrough pain -- a brief flare-up of severe pain -- in certain adult cancer patients.

January 25, 2008

A European Union advisory panel has recommended approval for Boehringer Ingelheim blood clot drug Pradaxa, a potential blockbuster that will compete against Bayer's Rivaraxoban.

January 24, 2008

The benefits of Adolor Corp and GlaxoSmithKline's experimental bowel drug Entereg outweigh its risks, U.S. regulatory experts said on Wednesday.

January 24, 2008

Cangene Corp said on Thursday that the U.S. Food and Drug Administration has approved its Accretropin recombinant human growth hormone injection.

January 24, 2008

European regulators on Thursday recommended that patients with heart disease or leg pains -- a possible sign of heart problems -- should not take GlaxoSmithKline's diabetes drug Avandia.

January 24, 2008

Europe's drug watchdog on Thursday said it would make no changes to the label of Merck & Co's cervical cancer treatment Gardasil, saying the benefits outweigh any risks.

January 24, 2008

Botox and a similar injection should come with strong warnings following reports of 16 deaths and other serious problems after the botulinum toxin spread inside the body, a U.S. consumer group said on Thursday.

January 24, 2008

European regulators on Thursday recommended the use of Pharmion's Thalidomide drug for treatment of patients with a rare bone marrow cancer.

January 24, 2008

Europe's drug watchdog on Thursday recommended Cephalon's drug Effentora to treat chronic pain in certain adult cancer patients.

January 24, 2008

Johnson & Johnson said on Wednesday it had asked U.S. regulators to approve its experimental drug tapentadol for treatment of moderate to severe acute pain.

January 24, 2008

The benefits of Adolor Corp and GlaxoSmithKline's experimental bowel drug Entereg outweigh its risks, U.S. regulatory experts said on Wednesday.

January 24, 2008

Israel's Teva Pharmaceuticals has filed an application to produce a generic version of Belgian drug maker Solvay's cholesterol-fighting drug TriCor, the Belgium group said late on Wednesday. Solvay said its wholly owned subsidiary Fournier Laboratories Ireland Ltd, which was informed of the application, "remains fully committed to its fenofibrate franchise and is currently evaluating its options."

January 24, 2008

MiddleBrook Pharmaceuticals Inc said U.S. health regulators approved its once-daily antibiotic to treat strep throat in adolescents and adults, tripling the company's share price.

January 24, 2008

Labopharm Inc said on Thursday that the U.S. Food and Drug Administration has asked it for more information as it continues to evaluate approval for the company's once-daily formula for the pain-reliever Tramadol.

January 22, 2008

Stryker Corp said on Tuesday it is recalling some artificial hip products made at its Cork, Ireland, facility because the devices did not meet company manufacturing standards.

January 22, 2008

Biopharmaceutical company CytRx Corp said U.S. health regulators asked it to halt a mid-stage trial of its treatment of Lou Gehrig's disease because it needs more data, sending shares to a year-low in morning trade.

January 22, 2008

Stryker Corp said on Tuesday it is recalling some artificial hip products made at its Cork, Ireland, facility because the devices did not meet company manufacturing standards.

January 22, 2008

Marshall Edwards Inc, which is a unit of Novogen Ltd., said the U.S. health regulators have granted an orphan drug status to its triphendiol drug for the treatment of pancreatic cancer and bile duct cancer.

January 21, 2008

Daiichi Sankyo Inc, the U.S. subsidiary of Japan's Daiichi Sankyo Co Ltd, said U.S. health regulators approved its cholesterol drug Welchol to reduce blood glucose in adults with type 2 diabetes.

January 21, 2008

Abbott Laboratories Inc said on Friday that U.S. health regulators approved its rheumatoid arthritis drug Humira to also treat the skin condition psoriasis.

January 21, 2008

Health-care products maker Johnson & Johnson won U.S. approval to sell a new HIV drug called Intelence for patients with resistance to other therapies, U.S. officials said on Friday.

January 21, 2008

The label for a Johnson & Johnson contraceptive patch will include new data from a second study showing a higher risk of blood clots compared with birth-control pills, U.S. regulators said on Friday.

January 21, 2008

U.S. regulators have approved Novartis AG's Tekturna blood-pressure pill in combination with the diuretic hydrochlorothiazide (HCT), the Swiss drugmaker said on Monday. The Food and Drug Administration approved a combination of Tekturna, co-developed by Swiss biotech company Speedel, with HCT in a single tablet.

January 21, 2008

Drug maker Aurobindo Pharma Ltd said on Monday it has received the U.S. Food and Drug Administration approval to market its cefdinir antibiotic capsules in that country.

January 21, 2008

Indian drug maker Wockhardt Ltd has received the U.S. Food and Drug Administration approval to market fluoxetine hydrochloride capsules in multiple strengths, the regulator's website showed on Monday.

January 21, 2008

Cardiome Pharma Corp said on Monday that it did not receive a decision from the U.S. Food and Drug Administration on its New Drug Application for its Kynapid heart treatment.

January 18, 2008

The US Food and Drug Administration has issued a public health advisory concerning the serious consequences of administering edetate disodium instead of edetate calcium disodium (calcium disodium versenate).

January 18, 2008

A U.S. regulatory review of a drug to treat post-operative ileus (POI) found that the subsequent MI rate was similar to that seen with placebo, but the investigators said no conclusion could be drawn because of limited patient follow-up.

January 18, 2008

A U.S. regulatory review of a bowel drug from Adolor Corp and GlaxoSmithKline found a heart attack rate similar to that of a placebo, but the investigators said no conclusion could be drawn because of limited patient follow-up.

January 18, 2008

Celsion Corp said it reached an agreement with U.S. health regulators regarding the design of a late-stage trial of its liver cancer treatment.

January 18, 2008

An anti-smoking drug sold by Pfizer Inc will carry more prominent warnings that patients be monitored for unusual activity including agitation, depression and suicidal behavior, the company said on Friday.

January 17, 2008

ZymoGenetics Inc said U.S. health regulators approved its solution to stop bleeding from small blood vessels after surgery, sending its shares up 11 percent.

January 17, 2008

Children under 2 should not be given over-the-counter cough and cold medicines because they are too risky, U.S. health authorities warned on Thursday.

January 17, 2008

Teva Pharmaceutical Industries Ltd said U.S. health regulators granted final approval for its generic equivalent of Bristol-Myers Squibb Co's cholesterol treatment Pravachol 80 mg tablets.

January 17, 2008

Children under 2 should not be given over-the-counter cough and cold medicines because they are too risky, U.S. health authorities warned on Thursday.

January 17, 2008

APP Pharmaceuticals Inc said the U.S. Food and Drug Administration cleared its generic version of Bedford Laboratories' Polymyxin B Sulfate injection that is used to treat infections.

January 17, 2008

St. Jude Medical Inc on Thursday said U.S. and European regulators approved its Durata high-voltage lead, a wire used to carry electrical currents in implanted defibrillator devices used to control rapid heartbeats.

January 17, 2008

YM BioSciences said on Thursday the U.S. Food and Drug Administration had placed its phase II Acute Pain Study of its AeroLEF pain treatment on clinical hold demanding additional safety information, news which sent the company's stock down almost 15 percent.

January 17, 2008

French drugs group Sanofi-Aventis said on Thursday it did not expect Indian generics group Dr Reddy's Laboratories Ltd. to launch a copy of its blood thinning product Plavix.

January 16, 2008

St. Jude Medical Inc said U.S. health regulators have approved EnSite Fusion, its cardiac imaging software tool.

January 16, 2008

Hi-Tech Pharmacal Co Inc said U.S. regulators granted final approval for its fluticasone propionate nasal spray, an AB-rated generic version of GlaxoSmithKline's Flonase, for the treatment of seasonal and perennial, allergic and non-allergic rhinitis.

January 16, 2008

Stereotaxis Inc said the U.S. health regulators approved its partnered magnetic irrigated catheter for treatment of complex arrhythmias, or irregular heartbeat.

January 16, 2008

MAP Pharmaceuticals said it reached an agreement with the U.S. Food and Drug Administration on the protocol for the first late-stage clinical trial of its migraine treatment, MAP0004.

January 15, 2008

U.S. regulators cleared a new genetic test on Monday that helps predict tumor recurrence and long-term survival in breast cancer patients with higher risk of recurrence.

January 15, 2008

U.S. regulators have warned medical device maker Stryker Corp about manufacturing problems linked to some malfunctioning hip implant parts.

January 15, 2008

GlaxoSmithKline, Europe's biggest drugmaker, said on Tuesday its once-daily treatment for allergic rhinitis, Avamys, had been approved by the European Commission.

January 15, 2008

U.S. regulators have warned medical device maker Stryker Corp about manufacturing problems linked to some malfunctioning hip implant parts.

January 15, 2008

PreMD Inc lost more than 75 percent of its stock value on Tuesday after the U.S. Food and Drug Administration rejected its regulatory claim submission for its point-of-care skin cholesterol test.

January 15, 2008

U.S. regulators cleared a new genetic test on Monday that helps predict tumor recurrence and long-term survival in breast cancer patients with higher risk of the cancer returning.

January 15, 2008

Biogen Idec and Elan Corp won U.S. approval on Monday to market their drug Tysabri (natalizumab ) for treating Crohn's disease.

January 15, 2008

Biogen Idec and Elan Corp won U.S. approval on Monday to market their drug Tysabri for treating the bowel disorder Crohn's disease.

January 15, 2008

ZymoGenetics Inc said its partner Merck Serono, German drugmakerMerck KGaA's affiliate, received approval from U.S. health regulators for the design of a late-stage lupus trial testing the drug atacicept.

January 14, 2008

Teva Pharmaceutical Industries Ltd said on Monday that the U.S. Food and Drug Administration has granted tentative approval to a generic version of Eisai Co Ltd's Alzheimer's drug Aricept.

January 14, 2008

Generic drugmakerCaraco Pharmaceutical Laboratories Ltd said U.S. health regulators approved its generic version of Bristol-Myers Squibb's diabetes drug Metaglip.

January 14, 2008

Generic drugmakerCaraco Pharmaceutical Laboratories Ltd said U.S. health regulators approved for marketing its generic over-the-counter drug for relief of allergy and hives.

January 14, 2008

Genta Inc said the U.S. Food and Drug Administration has extended the review of the appeal the company had filed against the health regulator's refusal to approve its cancer treatment, Genasense.

January 14, 2008

French health authorities on Monday backed the use of Merck & Co's cervical cancer vaccine Gardasil over GlaxoSmithKline's rival product Cervarix.

January 14, 2008

King Pharmaceuticals Inc said the U.S. Food and Drug Administration approved revised labeling for its blood-clotting product, Thrombin-JMI.

January 10, 2008

U.S. health officials said on Wednesday they had warned seven pharmacies selling "bio-identical" hormones over the Internet that they were breaking the law with false and misleading claims about the benefits for menopausal women.

January 10, 2008

Noven Pharmaceuticals Inc said it received a warning letter from U.S. health regulators related to certain deficiencies in Current Good Manufacturing Practices at its Miami facility.

January 10, 2008

Wyeth and Progenics Pharmaceuticals Inc said Thursday that U.S. regulators have delayed a review of their experimental drug to treat opioid-induced constipation in order to further review certain safety data.

January 10, 2008

Britain's medicines advisory agency should assess all new drugs at launch but set a tougher initial cost hurdle for using them on the state health service, lawmakers said in a report on Thursday.

January 9, 2008

Barr Pharmaceuticals Inc said on Wednesday it has asked U.S. regulators to approve its generic form of French drugmakerSanofi-Aventis' blockbuster Eloxatin treatment for colon cancer.

January 9, 2008

Drug maker Wockhardt Ltd said on Wednesday it received the U.S. Food and Drug Administration's approval to sell anti-depression drug sertraline hydrochloride tablets in various strengths.

January 8, 2008

Adams Respiratory Therapeutics Inc. and Britain's Reckitt Benckiser Group Plc said they received antitrust approval from U.S. regulators for the acquisition of the U.S.-based drugmaker by the British company.

January 8, 2008

Vion Pharmaceuticals Inc said the U.S. Food and Drug Administration lifted the clinical hold on the late-stage trial of the company's lead anti-cancer drug, Cloretazine.

January 8, 2008

Eli Lilly and Co. on Tuesday said U.S. regulators approved once-daily use of two low-dose formulations of its Cialis anti-impotence treatment.

January 7, 2008

FDA officials issued an alert on Monday to highlight the possibility of severe bone, joint and muscle pain in patients treated with bisphosphonates.

January 7, 2008

Medical-device maker Vision-Sciences Inc said the U.S. Food and Drug Administration granted marketing approval for its video-based flexible cystoscope, used in bladder examination.

January 7, 2008

Jazz Pharmaceuticals Inc said it received orphan drug designation from U.S. health regulators for its JZP-8 product candidate used to treat recurrent acute repetitive seizures.

January 7, 2008

U.S. health officials issued an alert on Monday to highlight the possibility of severe bone, joint and muscle pain in patients who take certain osteoporosis medicines.

January 7, 2008

French customs officials have intercepted a shipment of 224,000 fake Viagra and Cialis anti-impotence pills worth 2.4 million euros ($3.5 million), the Budget Ministry said on Monday.

January 4, 2008

U.S. regulators said on Thursday they were reviewing two recent studies that provided more evidence of serious risks for some cancer patients treated with erythropoiesis-stimulating agents, also known as ESAs or Epo drugs, for anemia.

January 4, 2008

Japan's Takeda Pharmaceutical Co Ltd said on Friday it is seeking U.S. approval to sell Alogliptin, a diabetes drug the firm hopes to replace Actos as the major earner loses patent protection in 2011.

January 4, 2008

The U.S. Food and Drug Administration (FDA) is expected to declare as early as next week that meat and milk from cloned animals and their offspring is safe to eat, the Wall Street Journal reported on Thursday.

January 4, 2008

A new oral drug to improve control of blood sugar levels in adults with type 2 diabetes has been approved by Health Canada, the drug's manufacturer said on Thursday.

January 4, 2008

U.S. regulators said on Thursday they were reviewing two recent studies that provided more evidence of serious risks for some cancer patients treated with anemia drugs sold by Amgen Inc and Johnson & Johnson.

January 4, 2008

Drug makers Eli Lilly & Co and Daiichi Sankyo Co Ltdof Japan said Friday that they submitted a New Drug Application to the U.S. Food and Drug Administration for prasugrel, an oral anti-clotting drug.

January 3, 2008

U.S. regulators on Thursday said they approved a new test from Luminex Corp. to detect a dozen infectious respiratory viruses, including the strain of influenza that has been a major factor in epidemics.

January 3, 2008

Schering-Plough Corp said on Wednesday its experimental drug to reverse the effects of certain muscle relaxants used in general anesthesia during surgery would be reviewed on a priority basis by U.S. health regulators.

January 3, 2008

Sciele Pharma Inc said the U.S. Food and Drug Administration approved all four dosage strengths of its Sular formulation to treat high blood pressure.

January 3, 2008

Shire Plc said on Thursday that U.S. regulators approved three additional dosage strengths for its Vyvanse drug that treats attention deficit hyperactivity disorder.

January 3, 2008

GenVec Inc said the U.S. health regulators have recommended changes to its pancreatic cancer clinical trial, including changing the main goal of the study to measure overall survival rather than 12-month survival.

January 2, 2008

Becton, Dickinson and Co said on Wednesday it received clearance from the U.S. Food and Drug Administration for a test to quickly identify the presence of two health care-associated infections: Staphylococcus aureus and methicillin-resistant Staphylococcus aureus (MRSA).

January 2, 2008

Depomed Inc said U.S. health regulators have approved the 1000 mg strength tablets of Glumetza, an extended-release formulation of metformin, for patients with type 2 diabetes.

January 2, 2008

Israel's Teva Pharmaceutical Industries Ltd said the U.S. Food and Drug Administration gave final approval for a generic version of Dey L.P.'s bronchodilator, DuoNeb.

January 2, 2008

U.S. regulators have warned the medical unit of German conglomerate Siemens AG that an assessment tool it sells with some ultrasound systems requires separate regulatory approval.

January 2, 2008

Depomed Inc said U.S. health regulators have approved the 1000 mg strength tablets of Glumetza for patients with type 2 diabetes.

January 2, 2008

Becton, Dickinson and Co said on Wednesday it received clearance from the U.S. Food and Drug Administration for a test to quickly identify the presence of two deadly health care-associated infections: Staphylococcus aureus and methicillin-resistant Staphylococcus aureus, better known as MRSA.

January 2, 2008

Watson Pharmaceuticals Inc said U.S. health regulators have approved its generic version of Dey L.P.'s DuoNeb for treatment of bronchospasm associated with chronic obstructive pulmonary disease.

January 2, 2008

Varian Medical Systems said it received clearance from U.S. health regulators for its RapidArc radiotherapy technology for intensity-modulated radiation therapy.

January 2, 2008

Barr Pharmaceuticals Inc said its Barr Laboratories Inc unit received final approval from U.S. health regulators for its generic version of Roche Laboratories Inc's Kytril tablets.

January 2, 2008

Eli Lilly and Co plans to submit a U.S. application next week for its experimental blood-clot preventer prasugrel, the most important drug in its pipeline, a company spokesman said Wednesday.

December 31, 2007

Ranbaxy Laboratories Ltd, India's top drug maker by sales, said on Monday it had received final approval from the U.S. Food and Drug Administration to make and sell cetirizine hydrochloride tablets.

December 31, 2007

Drug maker Mylan Inc said its generic version of Salix Pharmaceuticals Ltd's Colazal capsules received final regulatory approval.

December 28, 2007

Drug maker Mylan Inc said on Friday that it will immediately start shipping a generic version of Pfizer Inc's allergy drug Zyrtec after receiving final U.S. regulatory approval.

December 28, 2007

Indian drug maker Ranbaxy Laboratories Ltd has received tentative approval from the U.S. Food and Drug Administration for galantamine hydrobromide oral solution, the regulator's Web site showed.

December 28, 2007

U.S. regulators said on Thursday said they approved a treatment for blood loss during and after surgery made by Germany's Fresenius.

December 28, 2007

U.S. regulators said on Thursday said they approved a treatment for blood loss during and after surgery made by Germany's Fresenius.

December 27, 2007

Suven Life Sciences Ltd said on Thursday it received its first U.S. product patent for experimental compounds being developed to treat disorders of the central nervous system.

December 27, 2007

Noven Pharmaceuticals Inc said U.S. health regulators gave tentative approval for its experimental drug, Stavzor, to treat bipolar disorder, migraine and epilepsy, sending its shares up 14 percent in late electronic trade.

December 24, 2007

Wyeth said on Monday that it received a second approvable letter from U.S regulators for bazedoxifene, a drug that helps prevent bone deterioration in post-menopausal women.

December 24, 2007

India's Dr. Reddy's Laboratories Ltd has received tentative approval from the U.S. Food and Drug Administration for heartburn drug pantoprazole sodium in the extended release tablet format, the regulator's Web site showed.

December 24, 2007

Wyeth said on Monday that it received a second approvable letter from U.S regulators for bazedoxifene, a drug that helps prevent bone deterioration in postmenopausal women.

December 24, 2007

Drug developer Pharmacyclics Inc said on Friday that the U.S. Food and Drug Administration turned down its application to market Xcytrin as a treatment for non-small cell lung cancer that has spread to the brain.

December 24, 2007

Jazz Pharmaceuticals Inc said the U.S. health regulator, Food and Drug Administration, needs more information before it approves the company's mental disorder drug, Luvox, for treatment of social anxiety disorder.

December 21, 2007

U.S. regulators have asked Pfizer Inc to provide additional data before they decide whether to approve an experimental antibiotic to treat skin infections, the company said on Friday.

December 21, 2007

Genta Inc said U.S. regulators extended the review period of Genta's request for correction of certain information related to data from a late-stage trial of its treatment for advanced melanoma, Genasense, for 60 days.

December 21, 2007

U.S. health officials on Friday issued a second warning about reports of deaths and dangerous side effects in patients who used Johnson & Johnson's Duragesic patch (transdermal fentanyl) or generic versions.

December 21, 2007

U.S. health officials on Friday issued a second warning about reports of deaths and dangerous side effects in patients who used Johnson & Johnson's Duragesic pain-killing skin patch or generic versions.

December 21, 2007

Fresenius Biotech, part of the Fresenius SE group, has applied to the European Medicines Agency (EMEA) for marketing authorisation for its experimental cancer drug Removab, it said on Friday.

December 21, 2007

German biotech firm Jerini AG said on Friday that U.S. regulators at the Food and Drug Administration have granted priority review of its Icatibant drug for the treatment of skin-swelling disease hereditary angioedema.

December 21, 2007

Dutch biotechnology firm Pharming is asking the European Medicines Agency to re-examine its decision to deny the European marketing application for its key Rhucin drug, the company said on Friday.

December 21, 2007

Pharmaceutical company Akorn Inc said U.S. health regulators reported the satisfactory resolution of issues related to good manufacturing practices at its Decatur, Illinois, facility.

December 20, 2007

Genzyme Corp said it got European approval to market Synvisc-One for pain relief from osteoarthritis of the knee.

December 20, 2007

The U.S. Food and Drug Administration should delay a decision on whether milk and meat from some cloned animals are safe to eat until additional safety studies can be conducted, a Democratic lawmaker and consumer groups said in separate statements on Tuesday.

December 20, 2007

Genzyme Corp said it got European approval to market Synvisc-One, an injection used for pain relief from osteoarthritis of the knee.

December 20, 2007

Indevus Pharmaceuticals Inc said U.S. health regulators declined to approve its bladder cancer therapy, Valstar, sending shares tumbling more than 51 percent in late electronic trade to a new year-low.

December 20, 2007

Hospira Inc said on Wednesday it won European approval to sell Retacrit, a generic version of erythropoietin, as a treatment for anemia associated with chronic renal failure and chemotherapy.

December 20, 2007

CV Therapeutics Inc said U.S. health regulators have approved new language for the product labeling for Ranexa (ranolazine), the company's treatment for chronic angina.

December 20, 2007

CV Therapeutics Inc said U.S. health regulators have approved new language for the product labeling for Ranexa, the company's treatment for chronic angina.

December 20, 2007

Hospira Inc said on Wednesday it won European approval to sell Retacrit, a generic version of erythropoietin, as a treatment for anemia associated with chronic renal failure and chemotherapy.

December 20, 2007

Medical device maker Abiomed Inc said U.S. health regulators approved its combination iPulse circulatory support system.

December 20, 2007

Medical device maker Abiomed Inc said U.S. health regulators approved its combination iPulse circulatory support system.

December 20, 2007

The U.S. Food and Drug Administration has approved Aurobindo Pharma Ltd's antibiotic cefdinir in the oral suspension form, according to the regulator's Web site.

December 18, 2007

GlaxoSmithKline Plc's cervical cancer vaccine Cervarix faces a delay in winning approval in the United States, putting it further behind Merck & Co Inc's rival product Gardasil.

December 18, 2007

Over-the-counter cold medicines made with phenylephrine appear effective for relieving nasal congestion in adults but the ingredient needs more study, a U.S. advisory panel said on Friday.

December 18, 2007

Galvus, a diabetes medicine produced by Novartis, has received a positive opinion from European health authorities after the firm made changes to prescribing recommendations due to liver safety concerns.

December 18, 2007

Medtronic Inc said Monday it received approval from regulators in Japan to sell its Sprint Quattro lead used with implantable cardioverter-defibrillators (ICDs) that treat rapid heart rhythms.

December 18, 2007

Reacting to a recent series of toy, food and drug recalls, the Canadian government pledged tighter regulations on Monday to try to prevent such problems in the future.

December 18, 2007

Genzyme Corp on Monday said the U.S. Food and Drug Administration approved a broader use of thyroid cancer treatment Thyrogen.

December 15, 2007

A Merck & Co Inc study failed to show that consumers could make appropriate decisions about whether to take a proposed over-the-counter version of cholesterol drug Mevacor, a U.S. advisory panel said in an 11-2 vote on Thursday.

December 15, 2007

The European Medicines Agency has recommended against approval of Neurochem Inc's Kiacta amyloidosis treatment, and the Canadian company said it might ask for a new review.

December 15, 2007

The European Medicines Agency said on Friday that new warnings for doctors and patients were needed to increase awareness of cases of suicidal thoughts linked to Pfizer Inc's new smoking cessation pill.

December 15, 2007

French biotechnology group NicOx said on Friday it expected to file a New Drug Application (NDA) with the U.S. Food and Drug Administration in mid-2009 for its osteoarthritis treatment naproxcinod.

December 15, 2007

The European Medicines Agency has recommended extending the use of three medicines from Roche Holding AG, including key drug Avastin.

December 15, 2007

The European Medicines Agency has recommended approval of Teva Pharmaceutical Industries Ltd's generic versions of the organ rejection drug CellCept, the watchdog said on Friday.

December 15, 2007

A U.S. advisory panel said on Thursday that an experimental device made by Hologic Inc to permanently sterilize women could be approved but recommended several post-marketing studies be required.

December 15, 2007

Javelin Pharmaceuticals said U.S. health regulators have suggested the company conduct one additional efficacy study for its experimental drug, PMI-150, a nasal formulation of anesthetic ketamin, prior to application for marketing approval.

December 15, 2007

The U.S. Food and Drug Administration is planning to release new testing requirements for drug-coated heart stents in the next few weeks, the regulatory agency's device chief, Daniel Schultz, told the Wall Street Journal.

December 14, 2007

Shares in Dutch biotechnology firm Pharming plummeted more than 17 percent on Thursday after the firm said it had been denied a European marketing application for its key drug Rhucin.

December 14, 2007

BioMarin Pharmaceutical Inc won U.S. approval for the first prescription drug to treat a serious genetic disorder called phenylketonuria (PKU), the U.S. Food and Drug Administration said on Thursday.

December 14, 2007

Neurocrine Biosciences Inc said on Thursday that it has received an approvable letter from the U.S. Food and Drug Administration for its experimental sleep drug indiplon capsules.

December 14, 2007

The European Medicines Agency said on Thursday it had the recommended the withdrawal of Novartis AG's pain drug Prexige because of the risk of liver damage.

December 14, 2007

Making a cholesterol drug available over the counter could give millions of Americans a new option to reduce the risk of heart disease and provide a major public health benefit, drugmakerMerck & Co Inc argued to a U.S. advisory panel on Thursday.

December 12, 2007

Merck & Co Inc has not shown that consumers can adequately understand if they should take a proposed over-the-counter version of cholesterol drug Mevacor, a U.S. drug reviewer said in documents released on Tuesday.

December 12, 2007

Generic drugmakerPerrigo Co said an approval from U.S. health regulators for a drug that treats stomach acid reflux disease from its partner Dexcel Pharma Technologies Ltd is expected to add 20 cents to 25 cents in its earnings per share for fiscal 2008.

December 11, 2007

The U.S. Food and Drug Administration on Monday said it has been reviewing the potential risk of hip fractures with best-selling heartburn drugs sold by AstraZeneca Plc.

December 11, 2007

The U.S. Food and Drug Administration on Monday said that following a comprehensive review, it found no evidence of a link between best-selling heartburn drugs sold by AstraZeneca Plc and heart problems.

December 11, 2007

Osiris Therapeutics Inc said U.S. health regulators granted fast track status to Prochymal, a stem cell therapy for acute graft-versus-host-disease, a reaction of donated stem cells against the patient's tissue.

December 11, 2007

U.S. regulators said on Monday they had cleared AstraZeneca Plc's best-selling heartburn drugs Prilosec and Nexium of links to heart problems, but disclosed a review of a potential risk for hip fractures.

December 11, 2007

Plans by GlaxoSmithKline Plc to market two long-lasting versions of its Requip medicine in the United States suffered a double blow on Monday.

December 11, 2007

GlaxoSmithKline Plc said on Monday it would not pursue plans to sell a controlled release version of its drug Requip, known as Requip CR, for the treatment of restless leg syndrome.

December 9, 2007

Indian drugmakerRanbaxy Laboratories Ltd has won tentative approval from the U.S. Food and Drug Administration to make a generic version of Eisai Co Ltd's Alzheimer's treatment Aricept, the regulator's Web site showed.

December 9, 2007

Amgen Inc said on Thursday it is talking with U.S. regulators about updating safety warnings for anemia drugs, after data from two studies stoked concerns about their use by breast and cervical cancer patients.

December 9, 2007

CV Therapeutics Inc said U.S. health regulators will evaluate the approval for potential anti-arrhythmic claims for its angina drug, Ranexa, as part of its review for an additional use of the drug.

December 7, 2007

U.S. regulators are likely to to update the public within days about any potential heart risks of AstraZeneca Plc's stomach-acid drugs, which are taken by more than 1 billion people worldwide.

December 7, 2007

Amgen Inc said on Wednesday the European Commission granted conditional marketing approval for its drug Vectibix as a treatment for metastatic colon cancer.

December 7, 2007

Cancer drug Avastin should not be approved to treat women with breast cancer, a U.S. advisory panel recommended on Wednesday.

December 6, 2007

U.S. health officials alerted the public Tuesday about the deaths of two patients who were treated with a prescription drug to control bed-wetting.

December 6, 2007

GE Healthcare, a unit of General Electric Co, was warned by U.S. health regulators that some of its X-ray equipment is defective, according to a letter posted on Tuesday.

December 6, 2007

An advert which said breast enlargement surgery was easy was condemned by British advertising watchdogs on Wednesday.

December 5, 2007

Drugmaker Mylan Inc said India-based Matrix Laboratories Ltd, which is majority controlled by Mylan, received tentative U.S. regulatory approval to market the generic version of Gilead Sciences Inc's AIDS drug Viread.

December 5, 2007

Lives are at risk because the U.S. Food and Drug Administration is woefully behind in the latest scientific advances and is under funded, a panel of advisers to the agency said at a public meeting on Monday.

December 4, 2007

Forest Laboratories Inc and Mylan Inc said on Sunday that both companies had received an approvable letter from the U.S. Food and Drug Administration for the hypertension drug Nebivolol.

December 4, 2007

China is to extend a campaign to clean up its scandal-laden pharmaceuticals industry, the State Food and Drug Administration said on Monday, calling its task curb corruption and counterfeiting "arduous".

December 4, 2007

Lives are at risk because the U.S. Food and Drug Administration is woefully behind in the latest scientific advances and is underfunded for its vast responsibilities, an expert panel will tell the FDA on Monday.

December 4, 2007

The U.S. Food and Drug Administration plans to loosen its stance on the ability of pharmaceutical companies to promote their drugs for uses not yet approved, a U.S. lawmaker said on Friday.

December 4, 2007

Novartis said on Monday that U.S. regulators approved its drug Diovan to treat high blood pressure in children and adolescents aged 6 to 16.

December 4, 2007

Thoratec Corp's newest implanted heart pump should be approved for keeping patients alive while they wait for heart transplants, a U.S. advisory panel unanimously said on Friday.

December 4, 2007

Benefits of Roche Holding AG's and Genentech Inc's Avastin in breast cancer should be weighed against toxic side effects including the potential for death, U.S. regulatory staffers said in documents released on Monday.

December 1, 2007

Eli Lilly and Co said on Friday that U.S. health regulators approved Cymbalta for the maintenance treatment of major depressive disorder in adults.

December 1, 2007

India's Aurobindo Pharma Ltd has received the U.S. Food and Drug Administration's approval for ondansetron hydrochloride oral solution, the regulator's Web site showed on Friday.

December 1, 2007

Abbott Laboratories Inc moved closer to joining the U.S. market for drug-coated heart stents on Thursday as an advisory panel backed the company's experimental device.

December 1, 2007

Barr Pharmaceuticals Inc said it received final approval from U.S. health regulators to market a generic version of Forest Laboratories Inc's painkiller, Combunox tablets 5mg/400mg.

December 1, 2007

Israel's Teva Pharmaceutical Industries Ltd said it received tentative approval from U.S. health regulators to market its generic version of GlaxoSmithKline Plc's Requip (Ropinirole HCl) tablets.

December 1, 2007

Caraco Pharmaceutical Laboratories Ltd said U.S. health regulators granted tentative approval for 5 mg, 10 mg and 20 mg of Escitalopram Oxalate tablets, a generic version of Forest Laboratories Inc's antidepressant Lexapro.

November 30, 2007

Belgian pharmaceutical group UCB said on Thursday that it had filed for approval with the U.S. Food and Drug Administration (FDA) its drug lacosamide for treating epilepsy and diabetic neuropathic pain.

November 30, 2007

German drugs and chemicals group Merck won European Union approval to market its Cyanokit product for the treatment of cyanide poisoning, it said on its website on Thursday.

November 30, 2007

Swiss biotech company Santhera Pharmaceuticals said on Thursday it had filed its idebenone drug for Friedreich's ataxia for approval in Canada, boosting its shares.

November 30, 2007

U.S. health advisers called for stronger warning labels on Wednesday on Cephalon biggest drug, Provigil, noting the treatment for sleep disorder narcolepsy is not recommended in children.

November 30, 2007

Forest Laboratories Inc. said on Thursday it will ask U.S. regulators in 2008 to approve use of anti-depressant Lexapro in adolescents, after the drug proved effective in a late-stage trial.

November 30, 2007

Barr Pharmaceuticals Inc said it received final approval from U.S. health regulators to market a generic version of Forest Laboratories Inc's painkiller, Combunox tablets 5mg/400mg.

November 30, 2007

U.S. health regulators on Thursday debated a consumer group's bid to boost regulation of salt in food and revoke the ingredient's "generally recognized as safe" status.

November 30, 2007

People should stop taking four traditional Chinese medicines on sale in Britain that contain an acid linked to cancer and kidney failure, the drug safety watchdog said on Thursday.

November 30, 2007

Trinity Biotech plc said the U.S. Food and Drug Administration has given clearance to market the TRIstat HbA1c system, which measures HbA1c or glycated hemoglobin.

November 30, 2007

British drug maker AstraZeneca Plc said U.S. health regulators extended market exclusivity for its breast cancer drug, Arimidex, by six months.

November 29, 2007

U.S. regulatory advisers on Wednesday are mulling whether to beef up warnings on GlaxoSmithKline's asthma drug Serevent following reports of several deaths in patients taking the drug.

November 29, 2007

U.S health advisers recommended on Tuesday stronger warnings on the labels of flu drugs made by Roche Holding AG and GlaxoSmithKline Plc, amid reports of abnormal and, in the case of the Roche drug, sometimes fatal psychiatric behavior.

November 29, 2007

Indian drug maker Wockhardt Ltd has received the U.S. Food and Drug Administration approval to market ulcer treatment, ranitidine hydrochloride tablets, according to the regulator's web site.

November 29, 2007

The U.S. Food and Drug Administration said on Tuesday that Novartis AG's organ rejection drug, Myfortic, increases risk of first-trimester miscarriage and birth defects.

November 29, 2007

The European Commission has approved Novartis AG's Tasigna drug for use in chronic myeloid leukaemia (CML) for patients who no longer respond to Glivec, the Swiss company said on Wednesday.

November 29, 2007

Merit Medical Systems Inc, which makes disposable medical devices, said it received regulatory clearance to sell its All Star hemostasis valve and the Prelude marker tip introducer sheath.

November 29, 2007

A Thoratec Corp study of an experimental implanted heart pump showed it narrowly missed a preset goal to gauge effectiveness, U.S. medical device reviewers said in documents released on Wednesday.

November 29, 2007

Biopharmaceutical company Adolor Corp and GlaxoSmithKline said the U.S. health regulator's advisory committee will review Adolor's new drug application for bowel drug Entereg.

November 28, 2007

Toshiba America Medical Systems Inc said it received clearance from U.S. health regulators to market AquilionONE, its diagnostic imaging computed tomography equipment.

November 28, 2007

Watson Pharmaceuticals Inc said the U.S. health regulators approved its generic form of Forest Laboratories Inc's Combunox, for the short-term treatment of acute, moderate to severe pain.

November 28, 2007

Natus Medical Inc said its manufacturing facility in Seattle was in compliance with regulatory requirements and had resumed production and shipping at the unit.

November 28, 2007

Chinese officials on Tuesday defended a system of having multiple departments oversee the nation's food and product quality, saying practice had shown this was the best way to tackle problems.

November 28, 2007

A U.S. Food and Drug Administration official called for higher safety standards in approving diabetes drugs in the aftermath of fears about links between a top diabetes drug and heart attack risk.

November 28, 2007

GlaxoSmithKline PLC sent misleading letters to health professionals touting its breast cancer drug Tykerb, U.S. health officials said in a letter released on Monday.

November 28, 2007

Wyeth on Monday said European regulators had approved its drug Torisel as a first-line treatment for advanced kidney cancer.

November 28, 2007

The safety of influenza drugs is under scrutiny as advisers to the U.S. Food and Drug Administration on Tuesday analyzed abnormal psychiatric behavior seen in some patients, especially children.

November 28, 2007

Biopharmaceutical company AspenBio Pharma Inc said it chose a faster clearance path for its blood test for appendicitis, driving its shares up almost 21 percent.

November 27, 2007

Encysive Pharmaceuticals Inc said it received a notice that Barr Laboratories Inc had filed an abbreviated new drug application for a generic version of its drug, Argatroban, to treat heparin-induced thrombocytopenia.

November 27, 2007

U.S and European regulators said on Monday they have eased the application process for orphan drugs, a move aimed at spurring development of treatments for rare diseases.

November 27, 2007

Meridian Bioscience Inc said it received clearance from the U.S. Food and Drug Administration to market two new upper respiratory tests.

November 27, 2007

St. Jude Medical Inc on Monday said U.S. regulators approved the sale of a new heart valve with technology designed to protect against hardening of the tissue due to calcification.

November 27, 2007

Targeted Genetics Corp said the U.S. Food and Drug Administration had removed the hold on the company's early-stage clinical trial of tgACC94 for inflammatory arthritis.

November 27, 2007

Schering-Plough Corp on Monday said the U.S. Food and Drug Administration accepted for review its new drug application for asenapine, which is used to treat schizophrenia.

November 27, 2007

Pharmaceutical company Akorn Inc said the U.S. Food and Drug Administration approved a supplemental biologics license application for a unit dose, preservative-free tetanus diphtheria vaccine.

November 27, 2007

Signalife Inc. said it has received regulatory clearance to market and sell its ambulatory event recorder throughout the United States, without prescriptions.

November 27, 2007

Merit Medical Systems Inc, which makes disposable medical devices, said it received U.S. health regulatory approval for its Resolve Biliary Catheter.

November 24, 2007

British medical devices firm Corin Group said on Friday that U.S. regulators had approved further sizes of its Cormet hip replacement product.

November 24, 2007

U.S. Food and Drug Administration staffers are recommending new warnings about psychiatric events observed in some patients taking Roche Holding AG's Tamiflu and GlaxoSmithKline Plc's Relenza, according to documents released on Friday.

November 23, 2007

Drug maker Aurobindo Pharma Ltd said on Thursday it has received approvals for five products from the U.S. Food and Drug Administration.

November 22, 2007

Spectrum Pharmaceuticals Inc said the U.S. Food and Drug Administration extended the action date for completing the review of its injectable ingredient used in the treatment of osteogenic sarcoma, a type of bone cancer found in children.

November 22, 2007

Labopharm Inc said on Wednesday the U.S. Food and Drug Administration responded to its appeal of the approvable letter for its once-daily tramadol, and that the agency will not overturn the letter, which was issued in May.

November 22, 2007

Swiss drugmaker Roche has submitted its experimental Actemra drug to the U.S. authorities for approval to treat moderate to severe rheumatoid arthritis in adults.

November 21, 2007

The U.S. Food and Drug Administration dealt a blow to Biovail Corp's hopes for quick approval of a new version of its bupropion anti-depressant treatment Tuesday by classifying the review period as a Class 2 case.

November 21, 2007

Novartis AG has withdrawn its application to extend the use of its bone drug Zometa in Europe, the European Medicines Agency said on Wednesday.

November 21, 2007

Drug delivery systems maker Delcath Systems Inc said U.S. health regulators allowed the company to resume patient enrollment in the late- and mid-stage trials of its system used in the treatment of certain liver cancers, sending the shares up 40 percent.

November 21, 2007

U.S. regulators approved wider use of Bristol-Myers Squibb Co's schizophrenia drug Abilify, to treat major episodes of depression in combination with current treatments, the drugmaker said on Tuesday.

November 20, 2007

The U.S. Food and Drug Administration (FDA) has approved Nexavar medicine to treat liver cancer, Bayer AG and Onyx Pharmaceuticals Inc said on Monday, extending the reach of their cancer drug.

November 20, 2007

China has "blacklisted" 10 domestically made cosmetics, saying they contained chemicals that could cause the skin to atrophy, become discoloured and be susceptible to disease, state media reported on Sunday.

November 20, 2007

Papworth Hospital can resume heart transplant operations after a review failed to find one single reason for a sharp rise in recent deaths, the health watchdog said on Monday.

November 20, 2007

Trendy yoga wear retailer Lululemon Athletica said on Friday it would comply with a Canadian government agency order to remove clothing labels that claim therapeutic benefits from fabrics said to contain seaweed.

November 17, 2007

Discovery Laboratories Inc said U.S. health regulators have accepted its response to the second approvable letter for its Surfaxin drug as complete, sending its shares up as much as 17 percent.

November 17, 2007

DexCom Inc said it has received approval to calibrate its seven-day continuous glucose monitoring system using any blood glucose meter cleared by the Food and Drug Administration. DexCom said with the approval patients will be able to calibrate the system without using a connection cable.

November 17, 2007

The European Medicines Agency on Friday recommended the use of Merck & Co Inc's Ivemend to help prevent chemotherapy-induced nausea and the use of Isentress for use in combination with other HIV treatments.

November 17, 2007

AstraZeneca Plc said on Friday that U.S. health regulators had approved Seroquel XR, an extended-release version of one of its top-selling drugs, as a maintenance treatment for adult schizophrenia patients.

November 17, 2007

Anglo-Swedish drugmakerAstraZeneca Plc said U.S. health regulators approved its once-daily Seroquel XR extended-release tablets for maintenance treatment of schizophrenia in adult patients.

November 17, 2007

Wyeth said U.S. health regulators approved a delayed-release oral suspension version of its heartburn drug Protonix.

November 17, 2007

Orchid Chemicals & Pharmaceuticals Ltd said on Friday it received the U.S. Food and Drug Administration approval for its cefpodoxime proxetil antibiotic tablets in multiple strengths.

November 17, 2007

The Centers for Medicare and Medicaid Services has joined an investigation into how four Chicago transplant recipients contracted HIV and hepatitis C from a single organ donor, U.S. officials said on Friday.

November 17, 2007

Belgian pharmaceutical group UCB said on Friday its key drug Cimzia had failed to secure backing from a European medical panel, forcing a further launch delay that stripped more than 10 percent off its shares.

November 17, 2007

Abbott Laboratories said the European Medicines Agency recommended approval of its drug for the treatment of moderate to severe plaque psoriasis.

November 14, 2007

The U.S. Food and Drug Administration will announce its decision on GlaxoSmithKline Plc's diabetes drug Avandia within days, its deputy commissioner said Tuesday.

November 14, 2007

Dutch biotechnology firm Crucell said its rabies monoclonal antibody drug had been granted fast-track designation by the U.S. Food and Drug Administration, sending shares to a three-week high.

November 14, 2007

Biotechnology company Genzyme Corp said on Tuesday that U.S. regulators requested additional analyses and data related to its application to have Synvisc-One approved to treat knee pain from osteoarthritis.

November 14, 2007

Sanofi-Aventis said on Tuesday the European Commission had endorsed the positive opinion of the European Medicines Evaluation Agency (EMEA) for its anti-obesity drug Acomplia (rimonabant) to include type 2 diabetes trial results into the European label (section 5.1).

November 13, 2007

Biotechnology company ViroPharma Inc said the European Medicines Agency (EMEA) granted an orphan-drug designation for its experimental antiviral drug Camvia.

November 13, 2007

GeoPharma Inc said it received approval from U.S. health regulators to manufacture and sell Carprofen, the generic version of Pfizer Inc's non-steroidal, anti-inflammatory Rimadyl used in orthopedic surgeries for dogs.

November 13, 2007

Caraco Pharmaceutical Laboratories Ltd said it received tentative approval from U.S. health regulators for its Lamotrigine tablets, a generic version of GlaxoSmithKline Plc's Lamictal used in the treatment of bipolar disorder.

November 13, 2007

Abbott Laboratories said it received approval from U.S. health regulators for a new lower-strength tablet formulation of its HIV drug, Kaletra, which is also marketed as Aluvia in developing countries.

November 13, 2007

The U.S. Food and Drug Administration on Friday approved the nonprescription use of Zyrtec-D, an allergy drug made by Johnson & Johnson's McNeil unit, for adults and children 12 years or older.

November 10, 2007

AstraZeneca Plc has won U.S. approval to market its cholesterol-lowering drug Crestor to treat the clogging of arteries, which may boost sales of the blockbuster drug in an increasingly competitive market.

November 9, 2007

Merck KGaA has submitted an application to the European Medicines Agency for the marketing authorisation of sapropterin as an oral treatment for hyperphenylalaninemia, the German company said on Thursday.

November 9, 2007

The U.S. Food and Drug Administration (FDA) has approved the use of easypod, an electronic growth hormone injection device, German Merck KgaA said on Thursday.

November 9, 2007

Thoratec Corp. said on Thursday it was recalling all of its heart-assist devices after receiving reports of damaged components which resulted in several injuries and one patient death.

November 9, 2007

Warning labels on anemia drugs made by Amgen Inc and Johnson & Johnson have been strengthened to reflect concerns the drugs boost risk of heart attacks, stroke and death, regulators said on Thursday.

November 9, 2007

U.S. regulators have told a Johnson & Johnson unit to stop distributing a computer mouse pad and pen promoting heart failure drug Natrecor, in a letter released on Wednesday.

November 9, 2007

China and the United States will seal a cooperation pact next month to enhance drug safety and Beijing will launch a new sweep against the false advertising of medicines, China's drug watchdog said on Thursday.

November 8, 2007

India's Dr. Reddy's Laboratories Ltd has received approval from the U.S. Food and Drug Administration for anti-infective ciprofloxacin extended-release tablets, the regulator's Web site showed.

November 8, 2007

The Dutch government said on Wednesday it wants to promote the development of cannabis-based medicine and will extend the drug's availability in pharmacies by five years to allow more scientific research.

November 7, 2007

U.S. regulators have rejected Momenta Pharmaceuticals Inc's generic version of Sanofi-Aventis SA's top-selling thrombosis drug Lovenox, sending Momenta shares into a tailspin and Sanofi climbing.

November 7, 2007

Japanese drug maker Daiichi Sankyo Co said it is confident that prasugrel, a blood clot treatment it is developing with Eli Lilly, will win regulatory approval, brushing off negative views of analysts.

November 7, 2007

President George W. Bush on Tuesday proposed tougher inspection rules meant to keep dangerous food and other products out of the United States and said he wants broader power to recall food that is unsafe for U.S. consumers.

November 7, 2007

Bristol-Myers Squibb Co and Japan's Otsuka Pharmaceutical Co Ltd said U.S. health regulators approved their schizophrenia drug Abilify for ages 13 to 17.

November 6, 2007

Sciele Pharma Inc said the U.S. Food and Drug Administration extended the Prescription Drug User Fee Act (FDA action) date on Sciele's new Sular formulation for the treatment of high blood pressure to Jan. 2, 2008.

November 6, 2007

Vivus Inc said it reached an agreement with U.S. health regulators regarding the design of a late stage trial for its drug candidate, Qnexa, for the treatment of obesity and related co-morbidities.

November 6, 2007

Indian drug maker Cipla Ltd has received tentative approval from the U.S. Food and Drug Administration for cetirizine hydrochloride tablets, the regulator's Web site showed.

November 6, 2007

Abbott Laboratories on Monday said an advisory panel to the U.S. Food and Drug Administration later this month will review the company's experimental Xience V drug-coated stent.

November 6, 2007

Celsion Corp said U.S. health regulators requested clarifications and recommendations to the trial design of its experimental treatment for liver cancer, ThermoDox.

November 6, 2007

U.S. regulators have rejected GlaxoSmithKline Plc's experimental drug gepirone ER for adults with major depression.

November 3, 2007

Regeneron Pharmaceuticals Inc said U.S. regulators have extended the date for taking action on a priority review of the company's treatment for a rare chronic inflammatory disease known as CAPS.

November 3, 2007

U.S. regulators inspect few foreign makers of pharmaceutical ingredients and have no accurate count of how many companies supply the American market, a watchdog arm of Congress said on Thursday.

November 3, 2007

Natus Medical Inc said it received a warning letter from the U.S. Food and Drug Administration questioning the process of manufacturing of two devices, according to a regulatory filing.

November 1, 2007

GPC Biotech said on Wednesday it was unlikely to renew its filing to seek U.S. approval for experimental prostate cancer pill satraplatin.

November 1, 2007

Biotechnology company Genentech Inc is delaying a plan that would make it harder to repackage its Avastin cancer drug as an inexpensive treatment for eye disease.

November 1, 2007

Allergan Inc on Wednesday said U.S. regulators approved its glaucoma drug Combigan, an eye drop which treats the potentially blinding eye condition with two drugs that work through different mechanisms.

November 1, 2007

Bayer has applied to the European Agency for the Evaluation of Medicinal Products (EMEA) for approval to market rivaroxaban, an anticoagulant drug, the company said on Wednesday. Bayer said in a statement that study data revealed that rivaroxaban significantly reduced the risk of venous thromboembolism (VTE) in patients undergoing total knee replacement surgery compared with enoxaparin, the current standard therapy.

October 31, 2007

Barr Pharmaceuticals Inc on Tuesday said U.S. regulators had tentatively approved its generic version of Mirapex, a treatment for Parkinson's disease sold by privately held German drugmakerBoehringer Ingelheim.

October 31, 2007

The U.S. Food and Drug Administration said on Monday the Roche Holding AG organ rejection drug, CellCept, boosts the risk of pregnancy loss in the first trimester and also the risk of congenital malformations.

October 31, 2007

Japanese drug maker Eisai Co Ltd said on Tuesday it would delay submission of its U.S. and European applications for a drug candidate to treat Parkinson's disease.

October 30, 2007

Adams Respiratory Therapeutics Inc said U.S. health regulators are seeking additional data for the approval of Mucinex with codeine for the prescription treatment of coughs related to colds, inhaled irritants and chronic bronchitis.

October 30, 2007

Glenmark Pharmaceuticals Ltd said on Monday the U.S. Food and Drug Administration has allowed an additional study as part of phase II trials on its lead molecule, Oglemilast, boosting its shares.

October 30, 2007

A senior Republican lawmaker asked the U.S. Food and Drug Administration to confirm that an internal FDA group privately voted to keep the troubled diabetes drug Avandia on the market by a one-vote margin, according to a letter made public on Monday.

October 30, 2007

India's top drug maker by sales, Ranbaxy Laboratories Ltd, said on Monday it received tentative approval from the U.S. Food and Drug Administration to make and sell valsartan tablets in multiple strengths.

October 28, 2007

Cardiac surgery products maker ATS Medical Inc said the U.S. Food and Drug Administration cleared its semi-rigid annuloplasty ring used to repair heart valves, driving shares up more than 5 percent.

October 26, 2007

U.S. regulators have reprimanded Sanofi-Aventis for shoddy oversight of investigators doing a clinical study of its antibiotic drug Ketek, said a letter released by the government on Wednesday.

October 26, 2007

A warning is being added to Cephalon Inc's drug Provigil for excessive sleepiness because of the risk of serious skin rash and psychiatric symptoms, the U.S. Food and Drug Administration said on Wednesday.

October 26, 2007

KV Pharmaceutical Co said it received approval from U.S. health regulators for 100 mg and 200 mg strengths of Morphine ER tablets.

October 26, 2007

Swiss medical devices maker Synthes has been granted conditional approval from U.S. authorities for its ProDisc spinal disc replacement system for use in the neck area, or cervical spine.

October 26, 2007

A trial of Bayer AG's heart surgery drug Trasylol was halted after an increased risk of death from bleeding was linked to the treatment, the company said Thursday.

October 26, 2007

Genta Inc said it completed the filing of a formal appeal to the U.S. Food and Drug Administration, requesting the regulator to approve the use of Genasense injection plus chemotherapy for patients with relapsed/refractory chronic lymphocytic leukemia.

October 24, 2007

Biovail Corp said on Wednesday it submitted a response to the U.S. Food and Drug Administration's non-approval letter for a once-daily salt version of its anti-depressant bupropion and expected to hear from the agency shortly.

October 24, 2007

Wyeth on Wednesday said it has asked U.S. regulators to approve use of its already marketed Tygacil antibiotic as a treatment for pneumonia contracted outside of hospitals and nursing homes.

October 24, 2007

The nasal spray flu vaccine FluMist can be used in all healthy children aged 2 to 5, making the AstraZeneca Plc vaccine an alternative to shots for people aged 2 to 49, CDC advisers said on Wednesday.

October 24, 2007

U.S. Food and Drug Administration officials are pushing for a "black box" warning of the risk of heart attack on GlaxoSmithKline Plc'sdiabetes drug Avandia, the Wall Street Journal reported on Wednesday, citing unnamed sources.

October 24, 2007

Abbott Laboratories Humira, Amgen Inc's Enbrel and Johnson & Johnson unit Centocor's Remicade rheumatoid arthritis drugs were recommended on Wednesday for use in Britain's state health service.

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