The U.S. government warns that a 3/15 cyberattack against Health and Human Services computer systems was part of a disinformation campaign designed to...
FDA lifts a partial clinical hold against a Unum Therapeutics Phase 1 trial involving ACTR707 in combination with rituximab in patients with CD20+ B c...
FDA issues the fourth coronavirus Emergency Use Authorization to Thermo Fisher for its TaqPath COVID-19 Combo Kit diagnostic.
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.