Federal Register notice: FDA revokes the Emergency Use Authorization issued to Chembio Diagnostic Systems for the DPP Zika IgM Assay System because th...
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.
Federal Register notice: FDA sends to OMB an information collection extension for an International Council for Harmonization good clinical practice gu...
Federal Register notice: FDA announces a 9/15 Pediatric Advisory Committee meeting to discuss pediatric-focused safety reviews.
FDA proposes a rule establishing deadlines and contents requirements for the annual summary to be submitted by drug sponsors and manufacturers under t...
FDA lifts clinical holds for trials of three potential indications for CymaBay Therapeutics seladelpar.