Iqirvo wins EU’s conditional OK to treat primary biliary cholangitis
Iqirvo (elafibranor) has been conditionally approved in the European Union to treat adults with primary biliary cholangitis (PBC), either in combination with the…
Cholangitis
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…
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…
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