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By Leroy Leo and Sriparna Roy (Reuters) -A panel of advisers to the U.S. Food and Drug Administration, wary of the safety of Intercept Pharmaceuticals...
By Leroy Leo and Sriparna Roy (Reuters) -A panel of advisers to the U.S. Food and Drug Administration, wary of the safety of Intercept Pharmaceuticals’ oral drug for a type of fatty liver disease, recommended on Friday holding off on an accelerated approval of the medicine. The panel of outside experts voted 15-to-1 against the approval for obeticholic acid (OCA) based on surrogate biomarker data suggesting it was likely to benefit patients with NASH (non-alcoholic steatohepatitis) and fibrosis, or scarring, of the liver. The panel by a wide 12-to-2 margin voted that the benefits of I...
The committee members voted 15 to 1 to defer approval, citing concerns with increased risk for drug-induced liver injury while on the drug.
Governor Greg Gianforte, who has already authorized a bill to ban gender-affirming treatments for transgender minors this year, has until Sunday to sign or veto the new legislation, Senate Bill 458, or return it to the legislature for amendments. U.S. FDA approves Krystal Biotech's skin-disorder gene therapy The U.S. Food and Drug Administration on Friday approved Krystal Biotech Inc's first-of-its kind topical gene therapy for patients with a genetic skin disorder, sending its shares up 7% in afternoon trading.
(Reuters) -A panel of advisers to the U.S. Food and Drug Administration, wary of the safety of Intercept Pharmaceuticals' oral drug for a type of fatty liver disease, on Friday recommended holding off on an accelerated approval of the medicine. | May. 19