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Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a private, clinical-stage biopharmaceutical company dedicated to advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, today announced a Phase 1b/2 clinical...
The committee members voted 15 to 1 to defer approval, citing concerns with increased risk for drug-induced liver injury while on the drug.
NDA supported by robust NASH clinical development program, including two positive interim analyses from the Phase 3 REGENERATE study NDA includes...
NDA supported by robust NASH clinical development program, including two positive interim analyses from the Phase 3 REGENERATE study NDA includes detailed safety analysis of 2,477 patients with... | December 23, 2022
Data from Phase 3 REGENERATE study supporting positive benefit-risk profile of obeticholic acid in liver fibrosis due to NASH to be featured in late-breaker podium presentation Analysis... | October 31, 2022