The PDUFA date for FDA review of Ocaliva to treat NASH is extended to 26 June 2020.- Intercept Pharma
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Intercept Pharmaceuticals, Inc. announced that top-line data from its Phase III REVERSE trial will be delayed from previous guidance of near the end of the year and is now expected in the first quarter of 2022.
Intercept Pharmaceuticals, Inc. announced that it has formally notified the European Medicines Agency (EMA) of its decision to withdraw its Marketing Authorization Application (MAA) for obeticholic acid (OCA) for the treatment of liver fibrosis due to nonalcoholic steatohepatitis (NASH).
NGM Biopharmaceuticals, Inc. reported results from the 24-week Phase IIb ALPINE 2/3 study evaluating aldafermin in 171 patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH) with stage 2 or 3 liver fibrosis (F2/F3).