New drug application submission was based on positive data from the Phase III GLISTEN trial, which demonstrated significant ...

Drugmaker GSK revealed on Monday that a new drug application for its linerixibat asset had been accepted for review by the US ...

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for linerixibat for the treatment of cholestatic pruritus in patients with primary biliary cholangitis ...

London: GSK plc has announced the New Drug Application (NDA) for linerixibat, an investigational targeted inhibitor of the ...

GSK plc GSK announced that the FDA has accepted for review the new drug application (“NDA”) seeking approval of its ...

GSK plc GSK announced that the FDA has accepted for review the new drug application (“NDA”) seeking approval of its investigational targeted inhibitor of the ileal bile acid transporter ...

Linerixibat has not yet been approved in any market, but both the FDA and the European Medicines Agency have granted it orphan drug designation for treating cholestatic pruritus in PBC patients.

US FDA accepts for review GSK’s NDA for linerixibat to treat cholestatic pruritus in patients with PBC: London, UK Tuesday, June 3, 2025, 11:00 Hrs [IST] GSK plc announced the U ...

Linerixibat New Drug Application (NDA) accepted for review by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis (PBC) · If approved, linerixibat could address high ...

GSK plc (LSE/NYSE:LON:GSK) announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for linerixibat, an investigational oral treatment targeting ...