FarmaKeio Outsourcing, a drug compounding outfit, files a lawsuit against FDA seeking a court order to permit the compounding of sodium thiosulfate.
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.
Kinova recalls (Class 1) its Jaco assistive robotic arm to correct the device due to an increased fire hazard.
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.
