Ocaliva
Intercept Withdraws Ocaliva from US Market After FDA Safety Concerns
Intercept Pharmaceuticals; Ocaliva; liver disease; primary biliary cholangitis; FDA; drug withdrawal; safety concerns; liver injury; clinical trial hold; regulatory setbacks
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
Ocaliva (Obeticholic Acid) Linked to Increased Risk of Liver Failure in PBC Patients Without Cirrhosis
Ocaliva, obeticholic acid, primary biliary cholangitis (PBC), liver failure, liver injury, cirrhosis, FDA warning.
European Commission Revokes Marketing Authorization for Ocaliva, a Liver Disease Drug, Amid Regulatory Dispute
Ocaliva, European Commission, Marketing Authorization, Liver Disease, Primary Biliary Cholangitis (PBC), Advanz Pharma
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
Alfasigma’s PBC Treatment Ocaliva to Face FDA Advisory Committee in September
Alfasigma, Ocaliva, PBC, FDA advisory committee, primary biliary cholangitis, liver disease treatment