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GLEI / EVENT
FDA approves its first mesenchymal stromal cell therapy
Ryoncil's approval concerns a specific pediatric graft-versus-host disease indication.
FDA announced approval of Ryoncil for steroid-refractory acute graft-versus-host disease in pediatric patients aged two months and older. The agency described it as its first approved mesenchymal stromal cell therapy.
An indication-specific approval cannot be extended to general rejuvenation or unapproved stem-cell treatments. The source is FDA's dated bulletin.