Axogen获得FDA批准Avance的生物制品许可申请

2025-12-04 13:13

Axogen (AXGN) on Wednesday said that the U.S. Food and Drug Administration has approved the biologics license application for AVANCE (acellular nerve allograft-arwx).
Avance is an acellular nerve scaffold for the treatment of adult and pediatric patients aged 1 month or older with sensory, mixed, and motor peripheral nerve discontinuities.
Continued approval for these indications depends on verification and description of clinical benefit in confirmatory studies, Axogen (AXGN) added.
Commercial availability of the licensed Avance product is expected early in the second quarter of 2026. In the meantime, Avance remains available under the current tissue framework.

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