Leniolisib PDUFA Date (Pharming Group)
FDA PDUFA decision date for Leniolisib is January 31, 2026. Developed by Pharming Group. Indication: APDS in children aged 4-11. Current status: CRL.
Indication
APDS in children aged 4-11
Regulatory details
- Company: Pharming Group
- Therapeutic area: Rare Disease / Immunology
- Application type: sNDA
- Review type: Priority
- PDUFA date: 2026-01-31
- Outcome: CRL