FDA issues a draft guidance to help sponsors develop anti-rabies virus monoclonal antibody cocktails.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