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FDA sends Mesoblast a second complete response letter on its BLA for remestemcel-L for treating pediatric steroid-refractory acute...[ Price : $8.95]
FDA approves new labeling to permit several Biosense Webster cardiac ablation devices to be used without relying on a fluoroscopy ...[ Price : $8.95]
FDA solicits comments on a report outlining a structure for a public/private partnership to establish and operate a repository of ...[ Price : $8.95]
FDA approves an expanded indication for Mercks Ebola vaccine Ervebo (Ebola Zaire vaccine, live) to include its use in individuals ...[ Price : $8.95]
FDA clears an Imeka 510(k) for its Advanced Neuro Diagnostic Imaging (ANDI) quantitative imaging software, which is intended to ge...[ Price : $8.95]
Federal Register notice: FDA announces a 10/18-19 public meeting entitled Mitigating Clinical Study Disruptions During Disasters a...[ Price : $8.95]
Federal Register notice: FDA posts a draft guidance entitled PDUFA Waivers, Reductions, and Refunds for Fixed-Combinations and Sin...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Fixed-Combinations and Single-Entity Versions of Previously...