The EMA has started a review of GSK's treatment candidate for primary biliary cholangitis (PBC), linerixibat, offering hope ...

GSK's marketing application for linerixibat, targeting cholestatic pruritus in PBC patients, gains EMA acceptance based on phase III success.

Linerixibat currently holds orphan drug designation in the US and EU and remains under review for approval globally. GSK is currently trading at $37.99, down $0.08 or 0.22 percent on the New York ...

A regulatory filing seeking approval for linerixibat for the given indication is currently under review in the United States. A final decision from the FDA is expected on March 24, 2026.

EMA accepts GSK’s MAA for linerixibat for cholestatic pruritus in patients with primary biliary cholangitis: London, UK Tuesday, June 24, 2025, 09:00 Hrs [IST] GSK plc announced ...

Linerixibat works by inhibiting the ileal bile acid transporter (IBAT), reducing mediators of pruritus in circulation. Both the FDA and EMA have granted the drug orphan designation for treating ...

Linerixibat works by inhibiting the ileal bile acid transporter (IBAT), reducing mediators of pruritus in circulation. Both the FDA and EMA have granted the drug orphan designation for treating ...

GSK plc (LSE/NYSE:GSK) announced Monday that the European Medicines Agency (EMA) has accepted for review its marketing authorisation application for linerixibat, an investigational treatment for ...

· If approved, linerixibat could address high unmet medical need of patients living with cholestatic pruritus (relentless itch) and related sleep interference · Submission based on data from ...