obeticholic acid

FDA issues new warning on liver disease drugFDA is adding a Boxed Warning, its most prominent warning, on a liver disease medicine.
FDA Safety Communication for Ocaliva
FDA Safety Communication for OcalivaFDA issues new communication about risk of liver injury with Ocaliva (obeticholic acid).
FDA approves rare liver disease drugFDA recently granted accelerated approval for obeticholic acid (Ocaliva, Intercept Pharmaceuticals, Inc.) for the treatment of primary biliary cholangitis.
FDA committee recommends approving rare liver disease drugFDA advisory committee recently voted to recommend approval of obeticholic acid (Ocaliva, Intercept Pharmaceuticals, Inc.) for the treatment of primary biliary cholangitis (PBC). If approved, Ocaliva would be the first new treatment for PBC in nearly 20 years.