Mesoblast resubmits BLA for Ryoncil® in SR-aGVHD children to FDA after Phase 3 data review.
Mesoblast resubmits Biologics License Application (BLA) to the FDA for approval of Ryoncil® (remestemcel-L) in children with steroid-refractory acute graft-versus-host disease (SR-aGVHD). The resubmission follows FDA's review of Phase 3 study MSB-GVHD001 data, which suggests the data is sufficient to support the BLA. The filing addresses remaining Chemistry, Manufacturing, and Control (CMC) items.
July 09, 2024
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