FDA tells the DC federal court there are five reasons why it should dismiss a Norwich suit seeking to force the agency to approve an amended ANDA for ...
FDA clears a MediView XR 510(k) for its XR90 augmented reality-based surgical visualization and navigation platform.
Panelists at a Friends of Cancer Research meeting discuss the next steps to help make circulating tumor DNA available as an early endpoint in cancer r...
FDA clears a University of Utah Orthopedic Innovation Center 510(k) for its Bone Bolt System, an implant for percutaneous bone fracture fixation.
FDA says it is working with Pfizer to monitor the potential for drug shortages after a 7/19 tornado severely damaged Pfizers large sterile injectables...
Federal Register notice: FDA sends to OMB an information collection revision entitled Current Good Manufacturing Practice for Blood and Blood Componen...
Federal Register notice: FDA announces that seven information collections have been approved by OMB.
FDA grants Astria Therapeutics fast track status for STAR-0215 for treating hereditary angioedema.
