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
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