FDA gives traditional approval to Lillys Retevmo for some thyroid cancers in patients aged two and up.
A House Appropriations subcommittee slashes $450 million (6%) from FDAs fiscal year 2025 budget.
FDA clears an Avicenna.AI 510(k) for its CINA-VCF, a triage and notification artificial intelligence tool for detecting unsuspected vertebral compress...
FDA clears a Getinge 510(k) for its innovative clinical decision support software Talis +ACG (Advanced Clinical Guidance).
FDA clears a Spinal Simplicity 510(k) for its Wolffs Law Anterior Cervical Plate System.
FDA warns Malaysias TCT Neutraceuticals about CGMP violations in its manufacturing of OTC drugs.
Federal Register notice: CDER announces the Emerging Drug Safety Technology Meeting program for stakeholders to discuss the use of artificial intellig...
Insulet recalls (Class 1) its Omnipod DASH Insulin Management Systems Personal Diabetes Manager after receiving reports battery issues.