Linerixibat PDUFA Date (GSK)
FDA PDUFA decision date for Linerixibat is March 24, 2026. Developed by GSK. Indication: Primary biliary cholangitis (PBC) — cholestatic pruritus. Current status: Approved.
Indication
Primary biliary cholangitis (PBC) — cholestatic pruritus
Regulatory details
- Company: GSK
- Therapeutic area: Rare Disease / GI / Hepatology
- Application type: NDA
- Review type: Standard
- PDUFA date: 2026-03-24
- Outcome: Approved