NasdaqCM:AXGNMedical Equipment
FDA Biologic Approval For AVANCE Might Change The Case For Investing In Axogen (AXGN)
Axogen has reported that the FDA has approved the Biologics License Application for AVANCE, an acellular nerve allograft for treating peripheral nerve discontinuities in adults and children aged one month and older under a biologic regulatory framework.
This shift from tissue to biologic classification, with certain indications approved under the FDA’s Accelerated Approval pathway pending confirmatory trials, enhances regulatory rigor and could influence how clinicians, payers, and patients...