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FDA Says Genasense Not Approvable

[ Price : $8.95]

FDA says Gentas Genasense is not approvable for use with chemotherapy in treating patients with chronic lymphocytic leukemia.

FDA to Take Action Against Unapproved Quinine

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Federal Register Notice: FDA plans to take enforcement action against unapproved drug products containing quinine, quinine sulfate...

Comments Sought on International Drug Restrictions

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Federal Register Notice: FDA seeks written comments on World Health Organization recommendations to impose international manufactu...

FDA Advisers Vote Against 2 of 3 Ketek Indications

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Two FDA advisory committees vote against two of three indications for Sanofi-Aventis troubled antibiotic Ketek, and recommend a bl...

Elan, Biogen Idec Seek New Tysabri Indication

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Elan Corp. and Biogen Idec file a supplemental BLA for Tysabri, indicated for treating moderate to severe active Crohns disease.

New Trasylol Labeling Limits Patient Population

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FDA approves seven changes to labeling for Bayers Trasylol.

DTC Letters Have Limited Effectiveness: GAO

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The Government Accountability Office says FDAs inability to systematically determine which DTC ads to review and the length of tim...

Farm Antibiotics: Time for FDA to Think Outside the Box

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Consulting editor John Scharmann receives an unsatisfactory response from CVM about its continued approval of growth-promotant ant...

FDA Extends Review of Novartis Tekturna NDA

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FDA extends by up to three months its review of a Novartis NDA for its blood pressure drug Tekturna to allow additional data to be...

FDA Proposes to Expand Access to Investigational Drugs

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Federal Register Proposed rule: FDA proposes to amend its regulations to improve access to investigational drugs for patients with...