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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.
More on AxoGen
- Avance Nerve Graft FDA Verdict Approaches, Why Investors Are Watching Axogen
- Axogen, Inc. 2025 Q3 - Results - Earnings Call Presentation
- Axogen, Inc. (AXGN) Q3 2025 Earnings Call Transcript
- Axogen raises 2025 revenue growth target to at least 19% as BLA for Avance Nerve Graft nears key milestone
- AxoGen Q3 2025 Earnings Preview
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