Federal Register notice: FDA seeks comments on an information collection extension entitled Postmarket Surveillance of Medical Devices 21 CFR Part 82...
FDA approves the ManaMed ManaSport Class 2 ultrasound therapy device for pain relief and soft-tissue injuries.
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...