FDA clears a Heidelberg Engineering 510(k) for its Spectralis optical coherence tomography angiography (OCTA) Module with SHIFT technology, which is s...
FDA awards Neuren Pharmaceuticals a rare pediatric disease designation for its drug candidate NNZ-2591 and its use in treating Phelan-McDermid syndrom...
Federal Register notice: FDA seeks comments on an information collection entitled Diversity Action Plans (DAPs) for Clinical Studies.
FDA releases the form FDA-483 with seven observations from an inspection at the Englewood, CO-based Leiters Health outsourcing facility.
FDA recommends that Agenus not submit its BOT/BAL colorectal cancer treatment for accelerated approval.
FDA classifies as official action indicated an April inspection of Zydus Lifesciences injectables manufacturing facility at Jarod, Gujarat, India.
Aveo Oncology says its Phase 3 trial of Fotivda plus BMS Opdivo in some renal cell cancer patients did not meet the progression-free survival primary ...
FDA clears a Globus Medical 510(k) for its ExcelsiusFlex with total knee arthroplasty option.
