FDA alerts health care providers and facilities about the safe use of hyperbaric oxygen therapy devices following reports of serious injuries and deat...
FDA expands the approved use of Amgens cholesterol-lowering drug Repatha (evolocumab) to include adults at increased risk of major adverse cardiovascu...
Argenx says it will seek expanded approval for Vyvgart (efgartigimod alfa-fcab) to include adults with acetylcholine receptor antibody seronegative ge...
Vanda Pharmaceuticals urges FDA commissioner Marty Makary to reconsider a recent agency decision upholding approvals of two generic versions of Hetlio...
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...
