News

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.

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.

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 Wednesda