Medtronic recalls its Cobalt and Crome implantable cardioverter defibrillators because the devices have the potential for reduced shock energy (about ...
FDA clears a Dyad Medical 510(k) for its echocardiogram application called Echo:Prio.
Weeks after being administered a Novartis gene therapy, two children die of acute liver failure, according to the company.
Federal Register notice: FDA sends to OMB an information collection extension entitled Agreement for Shipment of Devices for Sterilization 21 CFR 801...
FDA posts nine guidances released by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal...
FDA approves a Roche a supplemental NDA for Xofluza (baloxavir marboxil) for treating acute uncomplicated influenza in certain children.
Citing lingering questions about pulse oximeters, four Senate Democrats urge FDA to initiate a post market study of the devices.
FDA grants Daiichi Sankyo accelerated approval for Enhertu for treating adult patients with unresectable or metastatic non-small cell lung cancer.
