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Bluebird Bio Says FDA Accepts BLA For Lovotibeglogene Autotemcel For Priority Review

Bluebird Bio Says FDA Accepts BLA For Lovotibeglogene Autotemcel For Priority Review

bluebird bio, Inc. (BLUE) announced Wednesday that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for lovotibeglogene autotemcel (lovo-cel) for priority review. The agency has set a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2023.
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