FDA Marks Thanksgiving With Two Approvals
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Biotechnology and pharmaceutical stocks were nearly flat during the holiday-shortened week as two long-awaited drugs received Food and Drug Administration approval.
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WASHINGTON - The Food and Drug Administration would gain authority to ensure the safety of prescription drugs, including the power to mandate label changes that warn of newly emerging risks, under a bill passed yesterday by the House.
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WASHINGTON -- The Food and Drug Administration, seeking to ease a major shortage of flu shots, is in discussions with two companies that sell flu vaccine in Canada and elsewhere, and have found a few million unsold doses.
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The federal Food and Drug Administration approved new labeling Thursday for Pfizer Inc.&#39;s Bextra drug to warn of possible serious skin reactions and heart-related problems for those who&#39;ve experienced coronary bypass surgery.
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Happy Holidays! Have some drug-enhancing technology.
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After two highly publicized incidents questioning the safety of some of the biggest selling prescription medicines, the Food and Drug Administration said yesterday it is moving to strengthen its safety monitoring efforts.
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Forest and Mylan receive FDA approval for Bystolic.
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Leading medical journal editors and lawmakers have rightfully focused a spotlight on how well the Food and Drug Administration monitors the safety of drugs after they are approved.
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TORONTO - A new but potentially costly treatment for multiple sclerosis has received fast-track approval from the US Food and Drug Administration.
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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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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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A second Food and Drug Administration advisory committee agreed that healthy children as young as 9 could be given the stimulant dextroamphetamine in an experiment, concurring with an ethics panel&#39;s recommendation last week.
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As the Food and Drug Administration prepares to make recommendations about Pfizer&#39;s (PFE:NYSE - news - research) Celebrex, the companies that ultimately pay for the drug aren&#39;t leaping to conclusions merely because one recent study showed patients taking
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Swiss drugmaker Roche Holding Ag said on Monday that U.S. health regulators approved its Tamiflu influenza treatment at two lower doses for children in a form with a longer shelf life that could be an advantage for use in stockpiling against a flu pandemic.
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Biogen and Elan receive an additional approval for Tysabri.
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Vendors know their route for the holidays: the mass market.
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The U.S. Food and Drug  Administration on Thursday ordered the review of preventative  studies involving Pfizer Inc.'s painkillers Celebrex and  Bextra, in light of recent evidence they may increase the risk  of heart attack and stroke.