Johnson & Johnson reports new icotrokinra (JNJ-2113) data from a Phase 3 studys subgroup analysis in moderate-to-severe plaque psoriasis patients.
Two Hyman, Phelps & McNamara attorneys say reductions in staff at FDA are resulting in significant delays in agency responses to Freedom of Informatio...
The Associated Press says FDA has reversed course and will permit some product reviewers and supervisors to work from home at least two days per week.
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Two stakeholders voice support for an FDA draft guidance on using AI in drug and biologic regulatory decision-making and ask for additional informatio...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.
