FDA sends PharmaTher a complete response letter on its ANDA for Ketarx (ketamine) and its use in anesthesia, sedation, and pain, among other uses.
FDA grants Distalmotion a de novo marketing authorization for the Dexter Surgical Robot for adult inguinal hernia repair.
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...
