Organogenesis' Biologics License Application For ReNu Receives FDA's Acceptance For Review To Treat Pain In Symptomatic Knee Osteoarthritis
Benzinga Newsdesk 4 months ago
NewsFDA
This page contains a summary, not the full article. Continue to benzinga.com to read the original report.
Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced that the U.S. Food
Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced that the U.S. Food and Drug Administration (FDA) has completed their filing determination and accepted for review the Company's Biologics License Application (BLA) for ReNu®, a cryopreserved, amniotic suspension allograft developed for the treatment of pain in symptomatic knee osteoarthritis (OA). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 24, 2027.