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...
FDAs National Center for Toxicological Research finds a new predictor for drug-induced liver injury.
DifGen asks FDA to require stability studies under refrigerated conditions for all ANDAs for prednisolone ophthalmic solution 1%.
FDA warns Atlanta, GA-based Dr. Han Phan about failing to ensure that a clinical investigation followed the investigational plan.
