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 ...

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 ...

GSK's NDA for linerixibat, for treating itch in PBC patients, gets FDA review with a decision due in March 2026.

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 ...

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).

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 ...

What we set out to do, and what we’ve continued working on, is exploring all the ways we could create the best possible ...

Primary biliary cirrhosis (PBC ... [1] This disease is characterized by chronic nonsuppurative destructive cholangitis (CNSDC) secondary to infiltrating cytotoxic T lymphocytes that gradually ...

The ACG has released new clinical guidelines for the management of ulcerative colitis and Crohn’s disease in adult ...

[14] To evaluate biliary strictures of undetermined etiology, the efficacies of variable diagnostic impetuses such as tumor markers, radiological evaluations, endoscopic approaches and tissue ...