FDA committee votes 10-1 against Ocaliva’s full approval for PBC
A U.S. Food and Drug Administration (FDA) advisory committee voted 10-1 that Ocaliva (obeticholic acid) doesn’t have a benefit-risk profile that would support its…
Cholangitis
Advanz gets suspension of decision to revoke Ocaliva EU approval
Advanz Pharma has secured a temporary suspension of a decision by the European Commission (EC) to revoke conditional approval of Ocaliva (obeticholic acid) for…
Organizations plan activities, events for PBC Awareness Month
September will be a busy month for the primary biliary cholangitis (PBC) community as organizations advocate for better patient care through conferences, walks, and…
PBC treatment setanaxib eases signs of liver damage: Trial data
Six months of Calliditas Therapeutics‘ investigational therapy setanaxib safely and significantly reduced signs of liver damage in people with hard-to-treat primary biliary cholangitis…
Orsini, Pantherx pharmacies will dispense Livdelzi for PBC in US
Specialty pharmacy services for Livdelzi (seladelpar), the newly approved second-line therapy for adults with primary biliary cholangitis (PBC), will be provided in the U.S.
FDA approves seladelpar, now Livdelzi, to treat adults with PBC
Note: This story was updated Aug. 20, 2024, to correct that Livdelzi is not a first-in-class therapy for primary biliary cholangitis. The U.S. Food…
Triple treatment combo works best for UDCA-resistant PBC: Study
A triple treatment combination adding fibrates — a type of medication that has shown promise in primary biliary cholangitis (PBC) — to dual therapy…
CM-101 shows signs of targeting all PSC aspects in Phase 2 trial
The experimental therapy CM-101 is generally safe and results in signs of improvement in liver health and health of the ducts that transport the…
EMA committee recommends Iqirvo approval for PBC in Europe
A European Medicines Agency (EMA) committee has recommended the approval of Ipsen‘s Iqirvo (elafibranor) as a second-line therapy for adults with primary biliary…
NGM Bio raises funds to launch clinical trial of aldafermin for PSC
NGM Biopharmaceuticals has raised $122 million in financing, which the California-based company will use to help launch a planned registrational clinical trial to test…
