FDA Rejects AstraZeneca's Exanta
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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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Cellegy Pharmaceuticals Inc. shares lost nearly half their value in Monday trading after the Food and Drug Administration rejected the company&#39;s ointment for treating pain from chronic anal fissure.
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US regulators won&#39;t approve Allergan Inc.&#39;s (AGN.N: Quote, Profile, Research) experimental treatment for the skin disorder psoriasis based on the data submitted, the company said on Monday.
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A weight loss drug used by thousands of Britons has been rejected by US safety officials because of an increased risk of suicide.
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AstraZeneca Plc, the UK&#39;s second-biggest drugmaker, delayed the regulatory filing of its diabetes medicine Galida by a year to 2007, a setback that comes a month after US scientists questioned
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BETHESDA, Md.  - A U.S. panel of medical experts  recommended on Friday that U.S. regulators reject AstraZeneca's  AZN.L AZN.N application to sell its anti-clotting drug  Exanta.
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The Food and Drug Administration (FDA) learned yesterday from AstraZeneca that a large clinical trial comparing Iressa (gefitinib) with placebo in patients with non-small cell lung cancer who had failed other courses of cancer therapy showed no survival
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WASHINGTON -- The Food and Drug Administration is preventing an agency scientist from presenting the largest, most up-to-date study of popular painkillers like Bextra, Celebrex and Vioxx during an FDA meeting next week on heart risks posed by the drugs, a US senator charged.
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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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US medical experts on Wednesday voted unanimously against recommending approval of Inex Pharmaceuticals Corp. and Enzon Pharmaceuticals Inc.
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WASHINGTON/LONDON  - An FDA review AstraZeneca  Plc's  under the name Coumadin.
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A newspaper advertisement for AstraZeneca Plc's cholesterol drug Crestor that touts patient safety is misleading and should no longer be published, regulators warned in a letter released Wednesday.
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AstraZeneca Plc suffered its third  setback in two months on Friday as lung cancer drug Iressa  failed to help patients live longer in a major clinical trial,  sending its shares down more than 8 percent.
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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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AstraZeneca Plc suffered its third setback in two months on Friday as lung cancer drug Iressa failed to help patients live longer
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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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Drugs giant AstraZeneca today acknowledged that its anti-clotting drug Exanta is unlikely to win US approval any time soon and revealed a one-year delay with another new drug, Galida, for diabetes.