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Mesoblast Limited announced on September 24, 2026, that it received approval from the United States Food and Drug…
MESOMesoblast Ltd
Mesoblast Limited announced on September 24, 2026, that it received approval from the United States Food and Drug Administration (FDA) to implement a new potency assay, T-cell Proliferation Inhibition BioAssay (TIBA), for release and stability monitoring of commercial lots of its FDA-approved mesenchymal stromal cell product Ryoncil. This assay will be used in conjunction with existing assays to ensure the consistency and clinical effectiveness of Ryoncil, which is approved for steroid-refractory acute graft versus host disease in pediatric patients aged 2 months or older. Mesoblast Limited operates as a global leader in developing allogeneic cellular medicines for inflammatory diseases.