FDA extends PDUFA date for Axogen's Avance Nerve Graft BLA to Dec 5, 2025

Axogen, Inc.

FDA deemed Axogen's August 22 submission a Major Amendment, extending PDUFA goal date by three months to Dec 5, 2025.
FDA now anticipates providing product labeling feedback in November 2025.
Submission included substantial new manufacturing and facility data not previously reviewed by the Agency.

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