US FDA Staff Question AstraZeneca Anti-Stroke Pill
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WASHINGTON/LONDON  - An FDA review AstraZeneca  Plc's  under the name Coumadin.
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Washington, Dec 16 : One-fifth of the US Food and Drug Administration (FDA) scientists surveyed as part of an official review have said they had been pressured to recommend approval of a new drug despite their reservations about its safety, effectiveness
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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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NEW YORK, September 9 (New Ratings) - The FDA has raised questions regarding AstraZenecaâs (AZN.NYS) blood thinner, Exanta. The leading pharmaceutical companyâs hopes had been pinned on Exanta, which
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U.S. health officials on Thursday  called on doctors to limit prescribing Pfizer Inc. painkillers  Celebrex and Bextra in light of recent evidence that they may  increase the risk of heart attack and stroke.
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Shares in AstraZeneca tumbled today after a key drug it has developed in the fight against strokes was provisionally rejected by US regulators.
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AstraZeneca Plc AZN.L AZN.N on  Friday said U.S. regulators did not approve its anti-clotting  drug Exanta.
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ATLANTA -- A new device that was studied in Atlanta has been approved by the US Food and Drug Administration to help stroke victims.
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Shares in AstraZeneca fell 109p to Â£25.10 yesterday on news that its potential blockbuster drug offering stroke prevention, Exanta, might face delays in getting American approval.
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A pair of Food and Drug Administration advisory panels called yesterday for new warnings for the widely used diabetes drug Avandia because of evidence that it significantly raises the risk of heart attack, but they stopped short of recommending that the drug be pulled from the market, as some FDA...
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A Food and Drug Administration panel tomorrow will consider one of the most urgent questions in medicine: what to do about the risk of blood clots caused by drug-coated stents, tiny medical devices implanted in the arteries of millions of people.
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U.S. health officials said on Friday  they would review whether to take regulatory action over Merck  & Co Inc and Schering-Plough's cholesterol medicine Vytorin  following the drug's failure to work better than a generic drug  in a study of plaque build-up in neck arteries.
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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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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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The safety of Celebrex and other pain relievers was questioned Wednesday as scientists in the United States and regulatory agencies in Europe said they feared such drugs might raise the same risk of heart problems as those blamed on the arthritis medicine Vioxx.
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The acting Food and Drug Administration (FDA) commissioner on Monday disputed a published report that said agency officials knew before Oct. 5 that British health authorities might suspend
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The US Food and Drug Administration (FDA) issued a warning about the generic drug naproxen, after the National Institutes of Health (NIH) halted a clinical trial involving patients at risk of developing Alzheimers.