United states food & drug administration (fda) notifies mesoblast that available clinical data from phase 3 trial appear sufficient to support bla submission for remestemcel-l in children with steroid-refractory acute graft versus host disease (sr-agvhd)

New york, march 25, 2024 (globe newswire) -- mesoblast limited (nasdaq:meso; asx:msb), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that u.s. fda has informed the company that following additional consideration the available clinical data from its phase 3 study msb-gvhd001 appears sufficient to support submission of the proposed biologics license application (bla) for remestemcel-l for treatment of pediatric patients with steroid-refractory acute graft versus host disease (sr-agvhd).
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