FDA announces an 11/6 public workshop entitled Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility...
FDA awards Diamyd Medical a Fast Track designation for Diamyd (rhGAD65/alum) for use in treating Type 1 diabetes in pediatric patients with Stage 1 or...
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...
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.
