FDA publishes a draft guidance updating its accelerated approval policies and procedures based on new authority from the 2023 Consolidated Appropriati...
FDA accepts for review a Genentech supplemental BLA for Columvi (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin for treating patien...
Federal Register notice: FDA determines that 29 drug products listed in the notice were not withdrawn from sale for reasons of safety or effectiveness...
FDA approves AstraZenecas Imfinzi to treat some adults with limited-stage small cell lung cancer.
Rayner Surgical petitions FDA to restrict approval of any ANDA citing Omidria as the reference-listed drug.
Protara Therapeutics reports encouraging data from a Phase 2 trial of its cell-based TARA-002 in certain high-risk non-muscle invasive bladder cancer ...
FDA grants EpicentRx a fast-track designation for its AdAPT-001 and its combination use with checkpoint inhibitors in treating recurrent or refractory...
FDA grants Field Medical a breakthrough device designation for its FieldForce Ablation System for treating sustained monomorphic scar-related ventricu...
