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Celgene Corporation
Fast track status granted for Revimid; agreement signed for Alkeran
May 14th, 2003
Celgene Corporation (CELG) announced that Revimid (CC-5013) received fast track designation from the U.S. Food and Drug Administration (FDA) for the treatment of myelodysplastic syndromes (MDS) and a distribution agreement has been signed for Alkeran. The FDA grants fast track designation to compounds that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease. Compounds that receive the designation are also eligible for priority review, which provides for a 6-month review of a new drug application by the FDA. "We are very encouraged by the emerging data on Revimid as a...
Source: Biotech Week (2003-05-14)
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