FDA issues a safety alert recommending that healthcare providers not use BioZorb Markers and BioZorb LP Markers manufactured by Hologic.
FDA approves an Iterum Therapeutics NDA for Orlynvah (sulopenem etzadroxil and probenecid) for treating certain uncomplicated urinary tract infections...
FDA grants Kind Pharmaceutical an orphan drug designation for AND017 and its use in treating sickle cell disease.
Smiths Medical recalls specific lots of its BLUSelect, BLUgriggs, and BLUperc products due to a manufacturing defect.
FDA approves Medtronics Affera Mapping and Ablation System with Sphere-9 Catheter for treating persistent atrial fibrillation.
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug-related applications.
PhRMA and USP recommend that FDA develop product class-specific guidances rather than product-specific guidances to spur the development of new biosim...
Federal Register notice: FDA announces a 12/4 Pharmacy Compounding Advisory Committee meeting to discuss various bulk drug substances being considered...
