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Medical Letter on the CDC & FDA

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Cancer Therapy



U.S. FDA grants fast track status for Fodosine in refractory T-cell leukemia



July 24th, 2005

BioCryst Pharmaceuticals, Inc., (BCRX) announced that the U.S. Food and Drug Administration (FDA) has granted "fast track" status to the development of Fodosine (forodesine hydrochloride), for the treatment of relapsed or refractory T-cell leukemia.

Fodosine is a transition state analog inhibitor with especially strong binding to the target enzyme. Currently being studied in a phase IIa clinical trial, Fodosine is BioCryst's lead product candidate.

The fast track programs of the FDA are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the...


Source: Medical Letter on the CDC & FDA (2005-07-24)

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