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...
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.
Federal Register notice: FDA makes available a draft revised guidance entitled Evaluating Target Animal Safety and Effectiveness of Antibacterial New ...
Federal Register notice: FDA makes available a final guidance entitled Marketing Submission Recommendations for a Predetermined Change Control Plan fo...
