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.
Georgia, North Carolina, Iowa and Colorado health officials report adverse reactions observed at vaccination sites after administering Johnson & Johns...