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FDA approvals up in '08, missed deadlines abound

December 22, 2008 — 10:13am ET | By John Carroll

The FDA will approve at least 21 new drugs this year, says the AP, an uptick from last year when only 18 first-of-a-kind therapies gained a green light from the agency. But industry observers note... Read more...

FDA Press Releases

FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications
Akorn, Inc. Responds to FDA Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl
GlaxoSmithKline statement on FDA Advisory Committee vote on use of asthma medicines containing long-acting beta-agonists
Acusphere, Inc.'s Stock Trading Halted Today; FDA Advisory Committee Meets to Discuss Imagify(TM)
ERBITUX Supplemental Biologics License Application for Advanced Non-Small Cell Lung Cancer Submitted To U.S. FDA

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