Panel Urges FDA Not to Approve Weight-Loss Drug
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An advisory panel of experts recommended unanimously yesterday that the Food and Drug Administration reject a new weight-loss drug after hearing testimony that it increases the risk of suicidal behavior.
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U.S. health officials and drugmaker GlaxoSmithKline Plc are likely to face tough questioning from lawmakers on Wednesday over their handling of data suggesting a heart risk with the widely used diabetes pill Avandia.
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An expert with the Food Drug Administration has accused the agency in Congress of having pressed him to withhold results of a study showing potential dangers of the anti-inflammatory drug Vioxx.
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U.S. lawmakers criticized the Food and Drug Administration's monitoring of the risks of the antibiotic Ketek (Sanofi-Aventis) and some other prescription drugs on Tuesday.
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SILVER SPRING, Maryland  - A U.S. advisory panel urged the government on Thursday to reject Merck & Co Inc's latest bid to sell a cholesterol-lowering drug without a prescription.
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GlaxoSmithKline PLC revealed Thursday that the U.S. Food and Drug Administration has declined to grant a priority review to its experimental cancer vaccine Cervarix, adding to pressure on the drug maker after controversy surrounding its diabetes drug Avandia.
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The company withdrew its application to gain federal approval for a weight loss drug after a meeting at which government advisers rejected the treatment on safety grounds.
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Nearly 20 percent of U.S. Food and Drug Administration scientists surveyed in late 2002 said they were pressured to approve or recommend approval of a medicine despite their reservations about the drug's risks or effectiveness, according to documents made public on Thursday.
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The US Food and Drug Administration says it plans to convene a panel of experts in February to discuss the safety of painkillers in the same class as the now-withdrawn drug Vioxx, but one member of the panel was asked not to come.
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A U.S. panel of nutrition experts on  Friday proposed new federal dietary guidelines that  acknowledged a link between soft drinks and weight gain, but  stopped short of recommending that overweight Americans eat  less sugar.
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A U.S. consumer group called for an  urgent Food and Drug Administration review of the safety of  aspartame on Monday, but the FDA said there was no immediate  need to do so despite a new study showing the sweetener may  cause cancer.
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A US advisory panel on Friday recommended against approving AstraZeneca&#39;s new stroke prevention medication, Exanta, citing concerns about the drug&#39;s effect on the liver.
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The panel is examining claims that GlaxoSmithKline tried to suppress a doctorâs criticism of its drug Avandia.
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The Food and Drug Administration has told a researcher that he cannot be part of an advisory panel that will review the safety of a class of drugs used to treat arthritis and pain.
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U.S. lawmakers criticized the Food  and Drug Administration's monitoring of the risks of the  antibiotic Ketek (Sanofi-Aventis) and some other prescription  drugs on Tuesday.
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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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WASHINGTON (CBS.MW) - An advisory panel to the Food and Drug Administration late Friday declined to endorse AstraZeneca&#39;s anti-stroke drug, Exanta.