U.S. Regulator Rejects Allergan Psoriasis Treatment
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U.S. regulators won't approve Allergan Inc.'s experimental treatment for the skin disorder psoriasis based on the data submitted, the company said on Monday.
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A US judge refuses a request to combine thousands of lawsuits involving the painkiller Vioxx into a class action.
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U.S. regulators have not approved Novartis AG's Prexige painkiller, the Swiss drugmaker said on Thursday, a move that had been expected after Australia withdrew the drug on concerns over liver side-effects.
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US regulators say recent newspaper ads for AstraZeneca&#39;s Crestor, a cholesterol-lowering drug, are false or misleading. An unusual letter from the Food and Drug Administration, sent Wednesday, dismissed as
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The Food and Drug Administration has told a researcher that he cannot be part of an advisory panel that will meet early next year to review the safety of a class of drugs, COX-2 inhibitors, used to treat arthritis and pain.
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BETHESDA, Md.  - A U.S. advisory panel on Friday  urged regulators to reject over-the-counter sales of Merck &  Co. Inc.'s cholesterol-lowering drug Mevacor because of doubts  the medicine could be used safely without a doctor's guidance.
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U.S. regulators said on Friday they were reviewing the safety of Allergan Inc's  Botox and a competing product, after reports of deaths and serious reactions in some patients.
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US regulators, who rejected Cyberonics Inc.&#39;s (CYBX.O: Quote, Profile, Research) device to treat depression in August, cleared the therapy
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Doctors should limit use of Pfizer Inc.&#39;s Celebrex and Bextra pain drugs while regulators continue to weigh their cardiovascular risks, the US Food and Drug Administration said today.
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The U.S. Food and Drug Administration denied charges it tried to suppress a safety official's findings that painkiller Vioxx, which was pulled from the market last week, raised heart attack risks.
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Doctors should limit use of Pfizer Inc.&#39;s Celebrex and Bextra pain drugs while regulators continue to weigh their cardiovascular risks, the US Food and Drug Administration said.
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The Thursday night rejection of Proctor &amp; Gamble&#39;s (PG:NYSE - news - research) female testosterone sex-drive patch Intrinsa by a Food and Drug Administration advisory panel will almost certainly delay efforts by BioSante to develop its own product, a
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AstraZeneca will have to take a charge against 2004 earnings after US regulators rejected its new anti-clotting drug Exanta, but a company spokesman has declined to say how large it will be.
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BETHESDA, Md.  - A U.S. advisory panel on Friday  urged regulators to reject over-the-counter sales of Merck &  Co. Inc.'s MRK.N cholesterol-lowering drug Mevacor.
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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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US medical experts on Wednesday voted unanimously against recommending approval of Inex Pharmaceuticals Corp. and Enzon Pharmaceuticals Inc.
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U.S. regulators approved the first generic rival to Johnson & Johnson's Duragesic pain relief skin patch, the U.S. Food and Drug Administration said on Friday.