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...
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...
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...
