AdvaMed and other device stakeholders urge the Centers for Medicare & Medicaid Services to overhaul how it covers new device technologies, warning tha...
Boston Scientific recalls (Class 1) its Carotid Wallstent Monorail Endoprosthesis due to a manufacturing defect that created an inner lumen smaller th...
A new Form FDA-483 cites significant GMP issues at the plant that makes Regenerons Eylea HD (aflibercept), delaying review of two related regulatory s...
FDA clears a Signos 510(k) for what the company says is the first over-the-counter glucose monitoring system designed specifically for weight manageme...
FDA is now publishing drug safety data on a daily basis, a shift the agency says will give the public faster access to information about adverse event...
FDA grants Keros Therapeutics an orphan drug designation for its investigational therapy KER-065 and its use in treating Duchenne muscular dystrophy.
FDA publishes a guidance with recommendations for 510(k) animal studies for dental bone grafting material devices.
FDA publishes a draft guidance with recommendations for approaches to assessing overall survival in oncology clinical trials.
