Breaking News: Intercept Reapplies for FDA Approval of Obeticholic Acid for Liver Fibrosis in NASH Patients
Intercept Resubmits New Drug Application to U.S. FDA for Obeticholic Acid in Patients with Liver Fibrosis NDA supported by robust NASH clinical development program Two positive interim analyses from the Phase 3 REGENERATE study NDA includes detailed safety analysis of 2,477 patients with nearly 1,000 patients on study drug for 4 years MORRISTOWN, N.J., Dec….