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
CHOLANGITIS
NewsAdvanz 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…
CHOLANGITIS
NewsOrganizations 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…
CHOLANGITIS
NewsPBC 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…
CHOLANGITIS
NewsOrsini, 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.
CHOLANGITIS
NewsFDA 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…
CHOLANGITIS
NewsTriple 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…
CHOLANGITIS
NewsCM-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…
CHOLANGITIS
NewsEMA 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…
CHOLANGITIS
NewsNGM 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…
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