Nipocalimab PDUFA Date (Johnson & Johnson)
FDA PDUFA decision date for Nipocalimab is April 30, 2025. Developed by Johnson & Johnson. Indication: Generalized myasthenia gravis (gMG). Current status: Approved.
Indication
Generalized myasthenia gravis (gMG)
Regulatory details
- Company: Johnson & Johnson
- Therapeutic area: Neurology / Immunology
- Application type: BLA
- Review type: Priority
- PDUFA date: 2025-04-30
- Outcome: Approved