FDA declines to fast-track Glaxo vaccine
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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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ID Biomedical of Vancouver, Canada&#39;s main supplier of flu vaccines, said Tuesday it will not sell 1.2 million doses of flu vaccine to the United States.
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The U.S. Food and Drug Administration warned GlaxoSmithKline Plc  on Thursday over misleading advertisements touting its hypertension drug called Coreg.
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WASHINGTON - The Food and Drug Administration said Friday that flu vaccine manufactured in Britain by Chiron Corp. is not usable. The announcement ended hopes that at least some batches of the vaccine were salvageable.
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The US Food and Drug Administration yesterday sought to distance itself from remarks by one of its top safety officials that raised concerns about key drugs made by Astrazeneca and Glaxo Smithkline.
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Mumbai, Oct. 15: GlaxoSmithkline (GSK) today announced a breakthrough in malaria vaccine development. This followed encouraging results from a paediatric safety and efficacy clinical trial of the vaccine in Africa.
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The Food and Drug Administration uncovered contamination and unsanitary conditions at a British flu vaccine manufacturing plant in 2003 but failed to re-inspect it until similar problems caused the loss of half the U.S. vaccine supply in October, the top FDA official said Wednesday.
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WASHINGTON A US Food and Drug Administration official on Friday &quot;categorically&quot; rejected accusations that the agency had failed to protect the public against dangerous drugs, especially Merck&#39;s Vioxx painkiller.
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U.S. health officials on Tuesday approved the importation of up to 4 million doses of influenza vaccine made by GlaxoSmithKline  , bringing the U.S. total to 65 million vaccines for this flu season.
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The Food and Drug Administration said yesterday that it does not plan to follow the lead of Canadian regulators who took a drug for attention-deficit hyperactivity disorder off the market because of reports that it has been linked to 20 sudden deaths and a dozen strokes, including some among children.
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HHS Secretary Tommy G. Thompson announced today that the Food and Drug Administration authorized the use of GlaxoSmithKline influenza vaccine, Fluarix, in the United States under an Investigational New Drug application.
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GlaxoSmithKline Plc's rotavirus vaccine has been linked to more pneumonia-related deaths and other reactions including bronchitis, U.S. regulatory staff said in documents posted on Friday.
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The Food and Drug Administration recently approved the first nonprescription drug for weight loss. Alli (pronounced AL-eye) is slated to hit shelves this year, according to its maker, GlaxoSmithKline (GSK). That move has been denounced by some who say it should not be made so readily available because of limited efficacy and safety concerns....
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The Food and Drug Administration is unlikely to clear influenza vaccine made by Chiron Corp. as safe for Americans to use this flu season, Dr. Lester M. Crawford, the agency's acting commissioner, said Friday. It was unclear whether the lack of vaccine might lead to more flu deaths this year.
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A Canadian company's cheap generic version of the blood thinner Plavix has been blocked from the U.S. market until at least 2011.
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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 potential heart risks of GlaxoSmithKline Plc's diabetes drug Avandia are still not clear, the head of the U.S. Food and Drug Administration told lawmakers who questioned the agency's oversight of the widely used pill on Wednesday.