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.
FDA says an Abbott recall of specific lots of its Dragonfly OpStar imaging catheter due to a potential loose marker band is Class 1.
Federal Register notice: FDA announces a 7/28-29 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting that will...
Federal Register notice: FDA seeks comments on an information collection extension entitled Postmarket Surveillance of Medical Devices 21 CFR Part 82...