Tabelecleucel (Ebvallo) PDUFA Date (Pierre Fabre Pharmaceuticals)
FDA PDUFA decision date for Tabelecleucel (Ebvallo) is January 10, 2026. Developed by Pierre Fabre Pharmaceuticals. Indication: EBV+ Post-Transplant Lymphoproliferative Disease. Current status: CRL.
Indication
EBV+ Post-Transplant Lymphoproliferative Disease
Regulatory details
- Company: Pierre Fabre Pharmaceuticals
- Therapeutic area: Oncology / Rare Disease
- Application type: BLA
- Review type: Priority
- PDUFA date: 2026-01-10
- Outcome: CRL