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…
Cholangitis
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…
FDA names volixibat, for itching due to PBC, a breakthrough therapy
The U.S. Food and Drug Administration (FDA) has designated Mirum Pharmaceuticals’ oral candidate volixibat a breakthrough therapy for the treatment of itching, or…
Iqirvo approved in UK for adults with PBC, problems with UDCA
U.K. regulators have approved Iqirvo (elafibranor) for adults with primary biliary cholangitis (PBC) who fail to respond to or cannot tolerate first-line…
