Smisson-Cartledge Biomedical recalls (Class 1) its ThermaCor 1200 Rapid Thermal Infusion System Disposable Sets because a cassette that warms fluids d...
FDA grants Cosmo Artificial Intelligence a de novo marketing authorization for the GI Genius, the first device that uses artificial intelligence to as...
Federal Register notice: FDA withdraws approval of five ANDAs from multiple holders because they have repeatedly failed to file required annual report...
Federal Register notice: FDA announces a 5/20 public meeting entitled Animal Drug User Fee Act.
Federal Register notice: FDA announces a 5/20 public meeting entitled Animal Generic Drug User Fee Act.
FDA tells Provention Bio that it has identified deficiencies with its BLA for diabetes therapy teplizumab that preclude labeling and post-marketing re...
FDA tells Iterum Therapeutics that it needs more time to review company-submitted materials related to the ongoing NDA review for for sulopenem etzadr...
FDA clears an Activ Surgical 510(k) for the ActivSight Intraoperative Imaging Module for enhanced surgical visualization.