U.S. FDA says reviewing Vytorin cholesterol drug
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U.S. regulators said on Friday they would review whether to take action over Merck & Co Inc's and Schering-Plough Corp's popular cholesterol medicine Vytorin after a study showed it was no better than a generic drug in preventing the build-up of fatty plaque.
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The FDA issues a health advisory for a top Pfizer drug.
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WASHINGTON The Food and Drug Administration has ordered a sweeping review of studies involving prescription painkillers like Celebrex and Bextra.
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The FDA will review its new cholesterol drug.
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Federal advisers who met last week to consider whether to restrict doses of popular antianemia drugs were themselves under scrutiny during the hearing. The Food and Drug Administration is considering a top-to-bottom reshaping of how it picks and uses the outside scientists who serve on the agency's advisory panels.
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BETHESDA, Md.  - U.S. advisers are set to decide  on Friday whether they will recommend approval for Merck & Co.  Inc.'s plan to sell a cholesterol-lowering medicine on  drugstore shelves without a prescription.
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The FDA decides to debate the company's lead drug.
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A document released by the FDA outlines its concerns with GPC's lead drug.
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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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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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U.S. FDA staff reviewers on Tuesday  said data on a new non-Hodgkin's lymphoma drug made by Inex  Pharmaceuticals Corp. and Enzon Pharmaceuticals Inc. may be  unreliable due to the trial's structure and size.
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An FDA review of AstraZeneca Plc&#39;s (AZN.L: Quote, Profile, Research) (AZN.N: Quote, Profile, Research) Exanta questioned the experimental drug&#39;s
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12/2/04- The FDA reviewers could decide if a drug dubbed the &quot;female Viagra&quot; should be recommended for government approval.
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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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A U.S. Food and Drug Administration  preliminary analysis found a level of heart-attack risk with  GlaxoSmithKline Plc&#39;s  diabetes drug Avandia  similar to what was reported in a study earlier this week, the  agency confirmed on Friday.
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The FDA grants a speedy review for Millennium's lead drug.
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Federal health advisers recommended against over-the-counter sales of a cholesterol drug, saying that patients need medical guidance in treating a condition that has no symptoms and may require drugs for life to stay healthy.