Maquet Cardiovascular recalls its Atrium Express Dry Suction Dry Seal Chest Drain in response to a related components recall by another company due to...
More than 260 congressional Democrats ask the Supreme Court to reverse lower court rulings restricting the use of the medical abortion drug mifepristo...
Just two days after agreeing to a consent decree, FDA says that Philips Respironics reported over 7,000 medical device reports and 111 death reports f...
Federal Register notice: FDA corrects a 12/21/2023 notice announcing the availability of a final guidance entitled Development of Monoclonal Antibody ...
CDRH director Jeffrey Shuren says the Center will propose down-classifying many in vitro diagnostic tests from Class 3 to Class 2 in the hope of incre...
FDA and EMA schedule a 2/1 virtual public discussion on innovative therapies for some cancers to mark World Cancer Day.
FDA sends Defender Pharmaceuticals a complete response letter on its NDA for intranasal scopolamine (DPI-386) for preventing nausea and vomiting induc...
Neuralink founder Elon Musk announces the first chip implant in the brain of a human clinical trial participant.
