Intercept Pharmaceuticals received approval from the U.S. FDA for their first orphan drug product, obeticholic acid, marketed in the U.S. as Ocaliva. The drug has been granted accelerated approval for the treatment of primary biliary cholangitis (PBC), previously known as primary biliary cirrhosis, in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. This indication is approved under accelerated approva...