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...
FDA adds empty IV containers to the medical device shortages list and says the shortage is likely to last until 3/2025.
FDA clears the Zimmer Biomet Persona SoluTion total knee replacement component for patients with sensitivities to bone cement or metal.
FDA grants Merus accelerated approval for Bizengri (zenocutuzumab-zbco) for certain adults with advanced, unresectable, or metastatic non-small cell l...
