The FDA has accepted for review the NDA for linerixibat for the treatment of cholestatic pruritus in patients with primary biliary cholangitis.

Ipsen has announced that its Iqirvo (elafibranor) tablets have been accepted by the Scottish Medicines Consortium (SMC) to treat adults with the rare cholestatic liver disease primary biliary ...

Your doctor may recommend a combination of medications, dietary supplements, and lifestyle changes to help manage primary biliary cholangitis (PBC). Some people eventually need a liver transplant ...

In 2015, the Chinese Society of Hepatology and the Chinese Society of Gastroenterology published a consensus on primary biliary cholangitis (PBC). In the past years, numerous clinical studies have ...

The drug has since been approved by the US Food and Drug Administration and recommended by the European Medicines Agency’s human medicines committee for PBC. These decisions were based on positive ...

The Gastrointestinal Drug Advisory Committee voted 13 to 1 with no abstentions that the benefits of Ocaliva on clinical outcomes in patients with PBC could not be verified with available data from ...

A primary biliary cholangitis (PBC) diagnosis can be life-changing. For many, it’s an emotional journey filled with questions, uncertainties and a need to redefine what life looks like with a ...

Primary biliary cholangitis (PBC) is a rare autoimmune disease affecting the bile ducts in the liver. When bile ducts become damaged, bile can build up in the liver, leading to inflammation and ...

Advanz wins stay, keeps PBC drug Ocaliva on Europe market for now. Sep. 5, 2024. By Nuala Moran. Advanz Pharma Ltd. has won a stay on the withdrawal of its primary biliary cholangitis (PBC) drug, ...

However, the future of obeticholic acid remains uncertain. Though initially approved in 2016 as a second-line therapy for PBC, subsequent trials' failure to establish adequate efficacy and safety ...

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to volixibat for the treatment of cholestatic pruritus in patients with primary biliary cholangitis.

The Gastrointestinal Drug Advisory Committee voted 13 to 1 with no abstentions that the benefits of obeticholic acid (Ocaliva, Intercept Pharmaceuticals) on clinical outcomes in patients with PBC ...