FDA Approves Axogen's Biologics License Application for Avance Nerve Allograft
Axogen Inc. has received FDA approval for its Biologics License Application for AVANCE® nerve allograft, now classified as a biologic for treating nerve discontinuities. Approved under the Accelerated Approval pathway, continued approval depends on confirmatory studies. Commercial availability is expected early Q2 2026.
Axogen Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA) for AVANCE® (acellular nerve allograft-arwx). The product is now classified as a biologic and is approved for the treatment of adult and pediatric patients aged 1 month and older with sensory, mixed, and motor peripheral nerve discontinuities. Certain indications were approved under the FDA’s Accelerated Approval pathway, with continued approval contingent upon confirmatory clinical studies. Commercial availability of the licensed Avance product is expected early in the second quarter of 2026. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Axogen Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9596626-en) on December 04, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)
