Alzheon says its Phase 3 valiltramiprosate trial in early Alzheimers disease patients did not meet its primary endpoint of slowing cognitive decline.
FDA clears the Dexcom G7 15 Day continuous glucose monitoring system.
FDA clears an Intuitive 510(k) for the SP SureForm 45 stapler for use with its da Vinci SP surgical system in thoracic, colorectal, and urologic proce...
Two stakeholders voice support for an FDA draft guidance on using AI in drug and biologic regulatory decision-making and ask for additional informatio...
FDA clears a Zeiss Medical Technology 510(k) for its Intrabeam 700, a robotic-assisted platform to support intraoperative radiation therapy.
Hyman, Phelps & McNamara attorney Kurst Karst says recent staff cuts at FDA that eradicated the Office of Generic Drugs Division of Policy Development...
FDA accepts for review an Outlook Therapeutics BLA resubmission for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizu...
The Government Accountability Office says HHS should have some mechanism in place to coordinate the activities of various HHS agencies responding to d...
