Committee recommends seladelpar approval in EU for treating PBC
A branch of the European Medicines Agency (EMA) has recommended that Gilead Sciences’ oral therapy seladelpar be approved in the European Union as a…
Cholangitis
Sleep disorders common in PBC, linked to severe disease: Study
Sleep disorders affect about half of adults with primary biliary cholangitis (PBC), and are associated with more severe disease and worse outcomes, according to…
PBC therapy Ocaliva pulled from EU market with court decision
Ocaliva (obeticholic acid) is no longer available to treat primary biliary cholangitis (PBC) across the European Union (EU), with an earlier decision…
Linerixibat eases ‘relentless’ PBC itching in Phase 3 trial, meeting goal
Treatment with linerixibat, an oral medication in development by GlaxoSmithKline (GSK), led to significant reductions in pruritus, or itching, among adults with primary…
PBC treatment Livdelzi shows benefits for 2.5 years in Phase 3 trial
After 2.5 years of Livdelzi (seladelpar) treatment, more than 4 in 5 adults with primary biliary cholangitis (PBC) saw meaningful reductions in liver…
FDA rejects full approval of Ocaliva as second-line PBC treatment
The U.S. Food and Drug Administration (FDA) has turned down a request by Intercept Pharmaceuticals for the full approval of Ocaliva (obeticholic acid) as…
American Liver Foundation funds 4 research projects in biliary atresia
The American Liver Foundation (ALF) has announced the eight winners of its 2024 Pilot Research Awards, with four of the awards going to scientist-led…
Iqirvo to treat PBC approved for public funding in England and Wales
England’s National Institute for Health and Care Excellence (NICE) has recommended that Iqirvo (elafibranor) be covered by the country’s National Health Service (NHS)…
RTY-694 chosen as lead treatment candidate for liver disease PSC
Rectify Pharmaceuticals has selected the oral small molecule RTY-694 as its lead treatment candidate for primary sclerosing cholangitis (PSC) and plans are underway…
Full approval on Ocaliva for primary biliary cholangitis delayed
The U.S. Food and Drug Administration (FDA) is still reviewing Intercept Pharmaceuticals’ application for full approval of Ocaliva (obeticholic acid) as a second-line…
