Organogenesis Announces FDA Acceptance of Biologics License Application for ReNu® for the Management of Symptomatic Knee Osteoarthritis
Organogenesis announced that the FDA has accepted for review the Biologics License Application for ReNu for the management of symptomatic knee osteoarthritis. The FDA has set a Prescription Drug User Fee Act target action date of April 24, 2027, moving the company closer to a potential launch of the first non-surgical biologic therapy for this indication.
Key figures
- Rct count
- 3
- Pdufa date
- April 24, 2027
- Trial patients
- 1300
- Current patient population
- 31000000
- Projected patient population
- 34000000
AI analysis
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