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…
Cholangitis
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…
CNP-104 shown to safely reduce liver scarring in PBC Phase 2 trial
Two infusions of the investigational therapy CNP-104 safely reduced liver scarring (fibrosis) and led to beneficial changes in disease-related immune cell populations among adults with…
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…
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…
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