Intercept Substance
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 Flags Concerns Over Intercept’s Ocaliva Approval in Advisory Committee Briefing
Ocaliva, Intercept Pharmaceuticals, FDA, Advisory Committee, Primary Biliary Cholangitis, Liver Disease
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