Axogen Provides Update on FDA Review Timeline for Avance Nerve Graft
FDA PDUFA goal date extended by three monthsALACHUA, Fla. and TAMPA, Fla., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Axogen, Inc. (Nasdaq: AXGN) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Biologics License Application (BLA) for Avance® Nerve Graft by three months to December 5, 2025. On August 22, 2025, the Company received a communication from the FDA indicating that the information submitted by the Company in response ...