Primary Biliary Cholangitis
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
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)
EMA Supports Approval of Gilead’s Liver Disease Drug from $4.3B CymaBay Acquisition
Gilead Sciences, CymaBay Therapeutics, seladelpar, primary biliary cholangitis (PBC), liver disease, EMA approval, $4.3 billion deal
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
GSK Advances Regulatory Filings for Linerixibat Following Successful Phase 3 Trial in PBC Itch Treatment
GSK, Linerixibat, PBC Itch, Phase 3 Trial, Regulatory Filings, Cholestatic Pruritus
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
Gilead Sciences Exceeds Q2 Expectations, Boosts Optimism for Seladelpar Decision
Gilead Sciences, Q2 earnings, seladelpar, PBC, liver disease, financial performance, pharmaceuticals
Extended Data from Gilead’s PBC Program Strengthens Case Ahead of FDA Ruling
Gilead, PBC Program, FDA Decision, Long-term Data, Primary Biliary Cholangitis