Axogen Announces FDA Approval of Biologics License Application for AVANCE® (Globe Newswire)
UF startup Axogen, Inc., announced that the U.S. Food and Drug Administration has approved the Biologics License Application for AVANCE® (acellular nerve allograft-arwx).
Atsena Therapeutics Announces Alignment With FDA on Regulatory Pathway to Approval for ATSN-201 in X-Linked Retinoschisis (XLRS)
UF startup Atsena Therapeutics received FDA approval to expand its Phase 1/2 LIGHTHOUSE study of ATSN-201 into a pivotal Phase 1/2/3 trial to support a BLA submission for treating X-linked retinoschisis (XLRS).
Axogen Completes Submission of Biologics License Application to U.S. Food and Drug Administration for Avance Nerve Graft®
UF startup Axogen, Inc., a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, announced that it has completed the rolling submission process for its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Avance Nerve Graft®.