Biliary Cholangitis
Gilead’s Seladelpar Receives Conditional EU Approval for Primary Biliary Cholangitis Treatment
Seladelpar, Gilead Sciences, primary biliary cholangitis, PBC, European Commission, conditional marketing authorization, RESPONSE trial, ursodeoxycholic acid (UDCA)
FDA Warns of Serious Liver Injury Risk with Ocaliva (Obeticholic Acid) in Patients with Primary Biliary Cholangitis
Ocaliva, obeticholic acid, liver injury, FDA warning, primary biliary cholangitis, liver disease, medication safety
FDA Denies Full Approval for Ocaliva in Primary Biliary Cholangitis, Accelerated Approval Stands
FDA, Ocaliva, Intercept Pharmaceuticals, primary biliary cholangitis, accelerated approval, rare liver disease
FDA Delays Decision on Full Approval for Amgen’s Lumakras and Intercept’s Ocaliva
FDA, PDUFA, Amgen, Intercept, Lumakras, Ocaliva, metastatic colorectal cancer, primary biliary cholangitis
FDA Advisory Committee Votes Against Ocaliva for Primary Biliary Cholangitis Due to Safety Concerns
Ocaliva, FDA, Primary Biliary Cholangitis, Liver Disease, Safety Concerns, Advisory Committee Vote
FDA Flags Concerns Over Intercept’s Ocaliva Approval in Advisory Committee Briefing
Ocaliva, Intercept Pharmaceuticals, FDA, Advisory Committee, Primary Biliary Cholangitis, Liver Disease
European Court Suspends EC’s Decision to Revoke Ocaliva’s Marketing Authorization
Ocaliva, European Court, EC decision, marketing authorization, primary biliary cholangitis, PBC, Advanz Pharma
Gilead’s $4.3B Acquisition of CymaBay Yields FDA Approval for Autoimmune Liver Disease Treatment
Gilead Sciences, CymaBay, FDA Approval, Autoimmune Liver Disease, Seladelpar, Primary Biliary Cholangitis
Alfasigma’s PBC Treatment Ocaliva to Face FDA Advisory Committee in September
Alfasigma, Ocaliva, PBC, FDA advisory committee, primary biliary cholangitis, liver disease treatment
Ipsen and Genfit Secure FDA Approval for Iqirvo, a Breakthrough Treatment for Primary Biliary Cholangitis
Ipsen, Genfit, Iqirvo, FDA approval, primary biliary cholangitis, liver disease, Intercept, Ocaliva