FDA sends Mesoblast a second complete response letter on its BLA for remestemcel-L for treating pediatric steroid-refractory acute graft versus host d...
FDA approves new labeling to permit several Biosense Webster cardiac ablation devices to be used without relying on a fluoroscopy workflow to perform ...
FDA solicits comments on a report outlining a structure for a public/private partnership to establish and operate a repository of antimicrobial use da...
FDA approves an expanded indication for Mercks Ebola vaccine Ervebo (Ebola Zaire vaccine, live) to include its use in individuals 12 months of age and...
FDA clears an Imeka 510(k) for its Advanced Neuro Diagnostic Imaging (ANDI) quantitative imaging software, which is intended to generate a report for ...
Federal Register notice: FDA announces a 10/18-19 public meeting entitled Mitigating Clinical Study Disruptions During Disasters and Public Health Eme...
Federal Register notice: FDA posts a draft guidance entitled PDUFA Waivers, Reductions, and Refunds for Fixed-Combinations and Single-Entity Versions ...
Federal Register notice: FDA makes available a draft guidance entitled Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrov...
