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ARTICLE | Data Byte

Ten PDUFA dates on FDA’s March agenda

Upcoming decisions include a label expansion for Alnylam’s Amvuttra, a new siRNA therapy for hemophilia, and more

March 14, 2025 12:50 AM UTC

Before the end of the month, FDA has at least 10 target action dates on therapeutics under review, including two siRNA therapies originated by Alnylam. 

Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) is awaiting a March 23 PDFUA that could expand the label of its transthyretin (TTR)-targeting siRNA therapy, Amvuttra vutrisiran, into the larger indication of TTR amyloidosis with cardiomyopathy (ATTR-CM). Therapy is already approved for ATTR with polyneuropathy. ...

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