FDA grants Kite accelerated approval for Tecartus (brexucabtagene autoleucel) for treating adult patients with relapsed or refractory mantle cell lymp...
FDA clears a Palliare 510(k) for its EVA15 insufflator and smoke evacuation system.
Taro Pharmaceuticals agrees to pay $205 million in criminal fines to resolve charges of conspiring to fix prices for generic drugs.
FDA approves an AstraZeneca NDA for Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for the maintenance treatment of patients with ...
FDA grants MyoKardia a breakthrough therapy designation for mavacamten, an oral, allosteric modulator of cardiac myosin for treating symptomatic, obst...
Internet of Things (IoT) security firm Ordr says many IoT medical devices have been subject to FDA recall as defective or risky.
U.S. senators Mike Enzi (R-WY) and Maggie Hassan (D-NH) introduce legislation that would help protect patients from counterfeit medical products that ...
Federal Register notice: FDA sends to OMB an information collection extension for an International Council for Harmonization good clinical practice gu...