A Ropes & Gray year-end review examines significant changes in FDA and Justice Department enforcement actions pertaining to regulated industries and s...
FDA lifts a clinical hold on Intellia Therapeutics MAGNITUDE-2 Phase 3 trial evaluating nexiguran ziclumeran for patients with hereditary transthyreti...
FDA sends a Warning Letter to Meridian Bioscience over serious quality system violations involving blood lead testing devices manufactured by its subs...
FDA issues MAST Biosurgery a Warning Letter after an August inspection cited serious manufacturing quality and safety reporting violations related to ...
Reuters reports that several drug companies say they are using artificial intelligence tools to speed up some of the time-intensive work needed for cl...
FDA approves a Scancell Holdings IND to begin a registrational Phase 3 trial of iSCIB1+ in patients with advanced melanoma.
FDA cites Pine Pharmaceuticals for multiple quality and sterility violations following a 10-day inspection of the companys drug outsourcing facility i...
A Health Affairs analysis on FDAs new pathway allowing drug approvals based on a plausible mechanism of action warns that the approach raises unresolv...
