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
WASHINGTON -- Several lots of Vicks Sinex nasal spray have been recalled because of bacteria found in the solution during a quality control inspection, the FDA announced. Drug manufacturer Proctor and Gamble issued the voluntary recall, citing possible contamination by B. ...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
("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
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
(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
(Updates with details on FDA letter, Medtronic comments, updated share price) The U.S. Food and Drug Administration has issued a warning letter to Medtronic Inc.'s (MDT) big heart-rhythm device unit detailing issues the agency found at that businesses' corporate headquarters in ...Read More
BOSTON— The Food and Drug Administration warned yesterday that taking Plavix -- the blood thinner that'sthe world's No. 2-selling drug -- with the stomach-acid medication Prilosec can reduce Plavix'seffectiveness by nearly half. Plavix generally is prescribed to help prevent blood ...Read More
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