Linvoseltamab PDUFA Date (Regeneron Pharmaceuticals)
FDA PDUFA decision date for Linvoseltamab is July 10, 2025. Developed by Regeneron Pharmaceuticals. Indication: Relapsed/refractory multiple myeloma. Current status: Approved.
Indication
Relapsed/refractory multiple myeloma
Regulatory details
- Company: Regeneron Pharmaceuticals
- Therapeutic area: Oncology
- Application type: BLA
- Review type: Priority
- PDUFA date: 2025-07-10
- Outcome: Approved