Catatan sumber primer
PenentuPersetujuan FDA
Axogen menerima persetujuan FDA untuk AVANCE acellular nerve allograft
FDA menyetujui BLA untuk AVANCE, mengubahnya dari produk jaringan manusia menjadi produk biologis berlisensi. Persetujuan ini mencakup diskontinuitas saraf sensorik ≤25 mm secara langsung dan >25 mm serta diskontinuitas campuran/motorik di bawah persetujuan dipercepat, bergantung pada uji konfirmatori. Ketersediaan komersial produk berlisensi diperkirakan awal Q2 2026.
Fakta utama
- Diajukan
- 4 Des 2025, 01.03
- Peristiwa
- Persetujuan FDA
- Arah
- Positif
- Perusahaan
AXGNAxogen- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
Kutipan sumber
EX-99.1 2 ex991axgnpressreleasedated.htm EX-99.1 - PRESS RELEASE Document Exhibit 99.1 Axogen Announces FDA Approval of Biologics License Application for AVANCE ® (acellular nerve allograft–arwx) ALACHUA, FL and TAMPA, FL – December 3, 2025 – Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical technologies for the restoration of peripheral nerve function, today announced that the U.S. Food and Drug Administration (the “FDA”) has approved the Biologics License Application (“BLA”) 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. The indications for sensory nerve discontinuities