The prescription painkillers Percocet and Vicodin should be banned, and Tylenol, sold over the counter, should be taken in reduced doses, because one of the three medications' ingredients, acetaminophen, is linked to liver damage, federal advisers said. Outside advisers to the ...Read More
NEW YORK -- Pfizer Inc. said Friday the Food and Drug Administration approved Geodon as a part of a combination maintenance treatment for bipolar disorder in adults. The new approval covers use of Geodon as an adjunct to lithium or valproate. The ...Read More
LEXINGTON - Biotechnology company Antigenics Inc. said today it will not seek approval for a potential kidney cancer treatment after a European advisory committee recommended against approving the drug candidate. The Committee for Medicinal Products for Human Use of The European ...Read More
SEATTLE (AP) - Biotechnology company Dendreon Corp. said Friday the Food and Drug Administration will make a regulatory decision on the potential prostate cancer vaccine Provenge by May 1. The drug is aimed at treating prostate cancer. It works as a ...Read More
* FDA sets Feb. 22, 2010, as new action date * Says FDA needs more time to review additional data Nov 20 (Reuters) - Covidien Plc (COV.N) said U.S. healthregulators extended the review period of its experimentalopioid pain drug by three months ...Read More
WASHINGTON -- Federal health experts yesterday brushed off lingering safety questions about apopular inhaler drug and suggested that it carry bolder benefit claims. The Food and Drug Administration's panel of lung specialists voted 11-1 in favor of new labelingabout the benefits ...Read More
Nov. 19 (Bloomberg) -- Protein Sciences Corp. failed toprove its experimental flu vaccine is safe enough to be approvedand more study is needed, a U.S. advisory panel said.
The shot, called FluBlok, is produced in less than twomonths by inserting flu ...Read More
Federal health experts say an inhaler drug from a German drugmaker works well enough to carry bolder claims about reducing coughing, wheezing and other respiratory problems. The Food and Drug Administration's panel of lung specialists voted 11-1 to allow Boehringer Ingelheim ...Read More
WASHINGTON -- Federal health experts on Thursday brushed off lingering safety questions about a popular inhaler drug and suggested it carry bolder benefit claims. The Food and Drug Administration's panel of lung specialists voted 11-1 in favor of new labeling about ...Read More
NEW YORK - Shares of Momenta Pharmaceuticals Inc. rose Thursday after an analyst upgraded the stock, saying Momenta will soon receive marketing approval for its version of the anti-clotting drug Lovenox. Momenta expects the Food and Drug Administration to make a ...Read More
WASHINGTON (Reuters) - Advanced Cell Technology, a small Massachusetts-based biotechnology company, said on Thursday it has asked for approval to test human embryonic stem cells in treating a rare cause of blindness. The company said it filed an IND, an investigational ...Read More
("FDA Advisory Board Votes Pfizer's Prevnar Vaccine As Effective" on Nov. 18that 3:13 p.m., EST and "UPDATE: FDA Board Considers Prevnar Vaccine Safe,Effective" on Nov. 18th at 3:53 p.m., EST, misspelled Dr. Bill Gruber's lastname in the 7th paragraph. The ...Read More
* Drug seen as multibillion-dollar a year seller * Submitted in Europe in October * To compete with Plavix, one of world's most used medicines (Adds details) LONDON, Nov 19 (Reuters) - Britain's AstraZeneca (AZN.L)came a step closer to getting one of its ...Read More
BETHESDA, Md. (AP) Federal health experts said Wednesday an updated version of Pfizer's best-selling anti-infection vaccine is safe and effective for infants and toddlers, despite company studies that failed to meet certain goals.
The Food and Drug Administration's panel of vaccine ...Read More
Genentech Inc. and partner Biogen Idec Inc. said Wednesday the Food and Drug Administration is withholding a decision to expand approval of Rituxan as a leukemia treatment, pending further discussion. Neither company disclosed the specific nature of the FDA's "complete response ...Read More
* FDA panel: Pfizer's Prevnar 13 safe, effective * FDA decision due by late December * Pfizer shares gain 1.4 pct (Recasts; Adds panel member quotes) BETHESDA, Md., Nov 18 (Reuters) - Pfizer Inc (PFE.N) won akey endorsement on Wednesday for a new ...Read More
BETHESDA, Md. — Federal health experts said Wednesday an updated version of Pfizer's best-selling anti-infection vaccine is safe and effective for infants and toddlers, despite company studies that failed to meet certain goals.
The Food and Drug Administration's panel of vaccine ...Read More
(Adds details on concerns over treatment for middle ear infections) Of DOW JONES NEWSWIRES WASHINGTON (Dow Jones)--An advisory board to the Food and Drug Administration recommended Wednesday that a new version of the children's vaccine Prevnar be considered safe and effective. Now marketed ...Read More
WASHINGTON, Nov. 18 (UPI) -- The U.S. Food and Drug Administration is warning patients against using the stomach acid reducer Prilosec with the anti-clotting drug Plavix. FDA officials said new data suggests when patients take both Prilosec (omeprazole) and Plavix (clopidogrel), ...Read More
WASHINGTON (Reuters) - A Senate committee passed legislation on Wednesday that would increase government oversight of the U.S. food supply, which has been battered by a series of high-profile recalls that have soured consumer confidence in the food safety system. The ...Read More
* FDA inspection was at Mounds View, Minn., facility * Medtronic to answer warning letter in 15 days * Has taken some actions to address FDA concerns * Shares down 51 cents to $39.69 (Adds detail, updates shares) CHICAGO, Nov 18 (Reuters) - Medtronic ...Read More
