Drugmaker Intercept Pharmaceuticals Inc.’s drug to treat a rare liver condition was conditionally approved an advisory committee to the European Medicines Agency.
FDA granted accelerated approval to Ocaliva, the first new medicine for primary biliary cholangitis in nearly 20 years.
An advisory panel to the U.S. Food and Drug Administration on Thursday unanimously backed the accelerated approval of Intercept Pharmaceuticals Inc’s drug to treat a rare liver condition. The drug, obeticholic acid (OCA), is being reviewed for use in patients with primary biliary cholangitis, a condition in which the body mistakes the bile ducts in […]
U.S. FDA staff members on Tuesday supported the use of Intercept Pharmaceuticals Inc.’s liver drug as a monotherapy in patients unresponsive to standard-of-care.