Despite questions raised by the US Food and Drug Administration, an advisory committee voted 8 to 2 that the available data support the efficacy of Mesoblast Limited’s remestemcel-L for treatment of pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGVHD).
In opening the 13 August virtual meeting of the Oncologic Drugs Advisory Committee, FDA’s Wilson Bryan, director of the Office of Tissues and Advanced Therapies in the Center for Biologics...
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