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

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

Interim results from the ongoing Phase III ASSURE trial demonstrated that Livdelzi maintained a consistent biochemical response in patients with primary biliary cholangitis. Results from an interim ...

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 ...

Ipsen has been given accelerated approval by the FDA for Iqirvo, which becomes the first dual PPAR alpha/delta agonist for rare cholestatic liver disease primary biliary cholangitis (PBC).

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 ...

Aramchol treatment leads to significant inhibition (2-fold, p<0.05) of TGFβ-induced hepatic fibrosis pathways while upregulating peroxisome proliferator activated receptor (PPAR) signaling ...

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

GSK has reported promising results with a drug to treat the severe itching that plagues patients with rare cholestatic liver disease primary biliary cholangitis (PBC). Interim results from the ...

The VANTAGE study is evaluating volixibat in patients with cholestatic pruritus caused by primary biliary cholangitis (PBC). "The extended VANTAGE analysis provides encouraging insights into the ...