Opdivo (nivolumab) PDUFA Date (Bristol Myers Squibb)
FDA PDUFA decision date for Opdivo (nivolumab) is April 8, 2026. Developed by Bristol Myers Squibb. Indication: Classical Hodgkin lymphoma stage III/IV (first-line). Current status: Approved.
Indication
Classical Hodgkin lymphoma stage III/IV (first-line)
Regulatory details
- Company: Bristol Myers Squibb
- Therapeutic area: Oncology
- Application type: sBLA
- Review type: Priority
- PDUFA date: 2026-04-08
- Outcome: Approved