FDA clears a LivaNova 510(k) for its Essenz In-Line Blood Monitor that provides continuous measurement of essential blood parameters to perfusionists ...
Four members of Congress from Michigan call on FDA to do more to prevent infections from contaminated bone grafts.
FDA reminds industry and others about its policy on using the FDA name and logo in any materials without being specifically authorized by the agency t...
FDA publishes a white paper on the assessment approach to be used as part of CDERs Quality Management Maturity program.
FDA commissioner Robert Califf says much remains to be done to combat the changing opioid crisis in the U.S.
FDA publishes a guidance on using real-world data and evidence to support drug and biological product regulatory decision-making.
FibroGen says its Phase 3 LELANTOS-2 trial of pamrevlumab for treating ambulatory patients with Duchenne muscular dystrophy did not meet the primary e...
Hamilton Medical recalls its Hamilton-C1, C2, C3, and T1 ventilators after receiving reports about software issues that may cause the devices to stop ...
