Mesoblast Seeks FDA Approval for Pediatric SR-aGVHD Therapy

Mesoblast Limited (AU:MSB) has released an update.

Mesoblast Limited, a global leader in cellular medicines for inflammatory diseases, announced the resubmission of its Biologic License Application for Ryoncil (remestemcel-L) to the FDA, targeting the treatment of children with steroid-refractory acute graft-versus-host disease (SR-aGVHD). The move follows the FDA’s indication that existing clinical data might be sufficient for approval, focusing on addressing Chemistry, Manufacturing, and Control (CMC) items. The product, which has shown promising results in Phase 3 trials, could significantly improve the low survival rates currently associated with SR-aGVHD in children.

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