FDA grants fast track designation for Pfizers ervogastat/clesacostat combination drug being developed to treat non-alcoholic steatohepatitis.
FDA grants Tvardi Therapeutics an orphan drug designation for TTI-101 for treating idiopathic pulmonary fibrosis.
FDA approves Serviers Tibsovo, indicated for treating some new acute myeloid leukemia cases, six weeks ahead of its goal date.
FDA accepts for priority review a Reata Pharmaceuticals NDA for omaveloxolone for treating patients with Friedreichs ataxia.
U.S. Senators Joe Manchin (D-WV) and Mike Braun (R-IN) introduce the Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endors...
FDA denies the Informed Consent Action Networks petition that the agency reconsider its response denying an earlier petition calling for changes to th...
A Friends of Cancer Research-funded analysis shows a positive correlation between drugs receiving a breakthrough therapy designation for non-small cel...
Attorney Nancy Taylor asks FDA to take steps to increase the use of OTC external analgesics in pain management.