Besremi (ropeginterferon alfa-2b) PDUFA Date (PharmaEssentia)
FDA PDUFA decision date for Besremi (ropeginterferon alfa-2b) is August 30, 2026. Developed by PharmaEssentia. Indication: Essential thrombocythemia (ET). Current status: Approved.
Indication
Essential thrombocythemia (ET)
Regulatory details
- Company: PharmaEssentia
- Therapeutic area: Rare Disease / Hematology
- Application type: sBLA
- Review type: Priority
- PDUFA date: 2026-08-30
- Outcome: Approved