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FDA issues a draft guidance to help sponsors develop anti-rabies virus monoclonal antibody cocktails.[ Price : $8.95]
FDA clears two Medtronic AccuRhythm artificial intelligence algorithms for use with the LINQ II insertable cardiac monitor.[ Price : $8.95]
FDA clears an Asensus Surgical 510(k) for its 5 mm diameter articulating instruments for use on the Senhance Surgical System techn...[ Price : $8.95]
FDA says a required post-accelerated approval trial of Oncopeptides Pepaxto found an increased risk of death.[ Price : $8.95]
Federal Register notice: FDA announces the fiscal year 2022 user fee rates for the establishment and reinspection fees related to ...[ Price : $8.95]
FDA accepts for priority review a Mycovia Pharmaceuticals an NDA for oteseconazole, an oral antifungal for treating chronic yeast ...[ Price : $8.95]
FDA advisory committee member G. Caleb Alexander lists the several ways he believes the agency erred in its accelerated approval o...[ Price : $8.95]
FDA approves a Synchron IDE for its Stentrode motor neuroprosthesis.