GSK plc (GSK) announced the FDA has accepted for review the NDA for linerixibat, an investigational targeted inhibitor of the ileal bile acid transporter, for the treatment of cholestatic pruritus in patients with primary biliary cholangitis. The PDUFA goal date is 24 March 2026.
The company said its application is based on positive data from the GLISTEN phase III trial, presented in May at the European Association for the Study of the Liver Congress.Linerixibat is currently not approved anywhere in the world.
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Business News
May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.