Lynavoy (linerixibat) approved by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis

GSK

19 March 2026 - Approval based on the positive GLISTEN Phase 3 trial with regulatory reviews underway in the EU, UK, Canada and China.

GSK today announced that the US FDA has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in adult patients with PBC.

Read GSK press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , Dossier , Registration , FDA