FDA says Bayer is making inadequate progress in a postmarket surveillance study of its Essure birth control device.
FDA grants Eli Lilly a fast track designation for tirzepatide and its use for treating adults with obesity, or overweight with weight-related comorbi...
Federal Register notice: FDA sets the medical device user fee rates and payment procedures for fiscal year 2023.
FDA clears an Aurora Spine 510(k) for its SiLO TFX MIS Sacroiliac Joint Fixation System.
Federal Register notice: FDA sets the rates for prescription drug user fees for fiscal year 2023.
FDA approves a Roche PMA for the Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify metastatic breast cancer patients with low...
Federal Register notice: FDA announces a 12/14 Cardiovascular and Renal Drugs Advisory Committee meeting to discuss a Viatris Specialty supplemental N...
Federal Register notice: FDA announces a 12/13 Cardiovascular and Renal Drugs Advisory Committee meeting to review a Cytokinetics NDA for omecamtiv me...
