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FDA publishes a draft guidance updating its accelerated approval policies and procedures based on new authority from the 2023 Cons...[ Price : $8.95]
FDA accepts for review a Genentech supplemental BLA for Columvi (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin...[ Price : $8.95]
Federal Register notice: FDA determines that 29 drug products listed in the notice were not withdrawn from sale for reasons of saf...[ Price : $8.95]
FDA approves AstraZenecas Imfinzi to treat some adults with limited-stage small cell lung cancer.[ Price : $8.95]
Rayner Surgical petitions FDA to restrict approval of any ANDA citing Omidria as the reference-listed drug.[ Price : $8.95]
Protara Therapeutics reports encouraging data from a Phase 2 trial of its cell-based TARA-002 in certain high-risk non-muscle inva...[ Price : $8.95]
FDA grants EpicentRx a fast-track designation for its AdAPT-001 and its combination use with checkpoint inhibitors in treating rec...[ Price : $8.95]
FDA grants Field Medical a breakthrough device designation for its FieldForce Ablation System for treating sustained monomorphic s...