FDA requires additional conditions of authorization for many molecular, antigen, and serology Covid tests to keep up with emerging mutations.
Federal Register notice: FDA announces a 12/2 Oncologic Drugs Advisory Committee meeting that will panel hear certain updates on NDAs approved under a...
Cordis recalls its Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands due to the potential for the bands to move or dislodge.
Emery Pharma asks FDA to recall and suspend sales of vitamin B6 and take other regulatory actions.
FDA releases an FDA-483 with 10 observations from an inspection at Prescription Labs Inc.
IntegraDose Compounding Services recalls nine lots of antibiotic cefazolin 2g in 20 mL syringes for injection and two lots of cefazolin 3g in 100 mL 0...
Washington Legal Foundation says the California Court of Appeals should reverse a trial court decision imposing $344 million in civil penalties on Eth...
FDA cautions Genesis Medical Center that it is marketing unapproved cellular and exosome products.