FDA issues the fourth coronavirus Emergency Use Authorization to Thermo Fisher for its TaqPath COVID-19 Combo Kit diagnostic.
FDA approves an Endologix PMA Alto Abdominal Stent Graft System (Alto) for endovascular abdominal aortic aneurysm repair.
Sen. Mark Warner (D-VA) writes HHS urging it to develop a long-term plan to move pharmaceutical manufacturing back to the U.S. to reduce reliance on f...
FDA posts a final guidance on slowly progressive, low-prevalence rare diseases with substrate deposition that result from single enzyme defects.
FDA clears a TransEnterix 510(k) for the Intelligent Surgical Unit (ISU) that enables machine vision capabilities on the Senhance Surgical System.
Federal Register notice: FDA announces a 4/16 Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting that will review the ...
Federal Register notice: FDA makes available a final guidance entitled Biological Product Deviation Reporting for Blood and Plasma Establishments.