Cholangitis

The U.S. Food and Drug Administration (FDA) has designated Mirum Pharmaceuticals’ oral candidate volixibat a breakthrough therapy for the treatment of itching, or…

U.K. regulators have approved Iqirvo (elafibranor) for adults with primary biliary cholangitis (PBC) who fail to respond to or cannot tolerate first-line…

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 (elafibranor) has been conditionally approved in the European Union to treat adults with primary biliary cholangitis (PBC), either in combination with the…

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 Pharma has secured a temporary suspension of a decision by the European Commission (EC) to revoke conditional approval of Ocaliva (obeticholic acid) for…

September will be a busy month for the primary biliary cholangitis (PBC) community as organizations advocate for better patient care through conferences, walks, and…

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…

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.

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…