FDA to review Vytorin cholesterol drug study
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U.S. regulators said on Friday they would review a study showing a Merck and Schering-Plough cholesterol drug worked no better than a generic in preventing the build-up of arterial plaque.
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Wyeth said on Tuesday that US regulators will review on an accelerated basis its experimental drug temsirolimus as a first line treatment for advanced renal cell carcinoma.
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WASHINGTON - The Food and Drug Administration (news - web sites) will examine clinical trial data for thousands of depressed adults to see if they, like children, suffered increased suicidal thoughts and behaviors while taking antidepressants.
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The cholesterol drug Vytorin became known for its commercials showing people who look oddly similar to foods like tacos and banana cream pie. But now Vytorin is getting attention that is anything but funny.
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A clinical trial of Zetia, a widely used cholesterol drug, has raised questions about its effectiveness and the behavior of pharmaceutical companies that conducted the study.
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Staff members of the Food and Drug Administration on Wednesday issued a report raising several questions about an experimental drug from Procter &amp; Gamble (PG:NYSE - news - research) designed to improve sexual desire in women whose ovaries have been
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MONDAY, Jan. 14 (HealthDay News)-- The long-awaited results of a trial of Zetia, a cholesterol-lowering drug prescribed to about a million Americans, shows the drug confers no medical benefit to users.
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By Thomas Ginsberg, The Philadelphia Inquirer  Dec. 19--Wyeth Pharmaceuticals said today that the FDA has agreed to conduct a fast-track review of the company's new kidney cancer-fighting drug, Torisel.
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ROCKVILLE, Md.  - The U.S. Food and Drug  Administration on Friday asked an outside group to review the  way the agency monitors safety risks of medicines after they  hit the market, such as Merck & Co. Inc.'s withdrawn painkiller  Vioxx.
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The US Food and Drug Administration is pushing for an expanded review of MDS Pharma&#39;s generic drug studies at its Montreal laboratories, and has requested a meeting with the company to discuss its concerns.
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A report to be released on Friday finds the U.S. Food and Drug Administration does very little to ensure the safety of patients who help test drugs in clinical trials, The New York Times reports.
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Scientists have developed a speedy way to monitor the effectiveness of cholesterol-reducing statin drugs.
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FDA advisory panel gives the nod to its heart drug.
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The U.S. Food and Drug Administration on Friday asked an outside group to review the way the agency monitors safety risks of medicines after they hit the market, such as Merck & Co. Inc.'s withdrawn painkiller Vioxx.
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U.S. Food and Drug Administration  staff reviewers on Tuesday questioned clinical data for  non-Hodgkin's lymphoma drug Marqibo, made by Inex  Pharmaceuticals Corp. and Enzon Pharmaceuticals Inc. .
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The Food and Drug Administration will consider whether one of the oldest of the cholesterol-lowering drugs, Mevacor, can be sold without a prescription.
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A veteran U.S. Food and Drug  Administration scientist will unveil new data on Thursday  before an expert panel charged with determining whether pain  relievers similar to Merck & Co. Inc.'s now-withdrawn Vioxx  should remain on the market.