FDA 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 drug Vytorin after a study showed it was no better than a generic in preventing the build-up of fatty plaque.
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A modified magnetic scan can tell patients whether cholesterol-lowering statin drugs are actually unblocking their clogged arteries, U.S. researchers reported on Monday.
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The results of a new study suggest that treatment with a cholesterol-lowering statin called simvastatin (Zocor) may have small negative effects on brain function.
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WASHINGTON/NEW YORK  - A U.S. Food and Drug  Administration reviewer who has accused the agency of being lax  in monitoring drug safety on Thursday said five medicines on  the market need closer scrutiny.
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Following results of recent clinical trials on popular cholesterol drugs, cardiologists are questioning whether a patientâs cholesterol should be all that matters.
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The chief executive of Merck &amp; Co on Wednesday said negative media coverage of a clinical trial of the company's blockbuster Vytorin cholesterol drug has unfairly overlooked benefits of the medicine.
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FDA whistle-blower David Graham says Crestor is the only cholesterol-lowering medication, or statin, that causes acute kidney failure, and that it carries a higher risk of rhabdomyolysis, a potentially life-threatening muscle disorder, than other statins.
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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to review the  way the agency monitors safety risks of medicines after they  hit the market, such as Merck & Co. Inc.'s withdrawn painkiller  Vioxx.
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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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US Food and Drug Administration staff reviewers on Tuesday questioned clinical data for non-Hodgkin&#39;s lymphoma drug Marqibo, made by Inex Pharmaceuticals Corp.
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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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Merck next month will make its second try for approval to sell cholesterol drug Mevacor without a prescription. If the Food and Drug Administration approves, cholesterol drugs would
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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. 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'sdiabetes drug Avandia similar to what was reported in a study earlier this week, the agency confirmed on Friday.
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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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ROCKVILLE, Md.  - The U.S. Food and Drug  Administration on Friday asked an outside group to review the  way it monitors safety risks associated with medicines already  on the market, such as Merck & Co. Inc.'s withdrawn painkiller  Vioxx.