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The U.S. FDA approves Ryoncil for treating a severe condition in children post-transplant.
The U.S. FDA has approved Ryoncil (remestemcel-L), the first mesenchymal stromal cell (MSC) therapy in the U.S., for treating steroid-refractory acute graft-versus-host disease (SR-aGVHD) in children aged 2 months and older.
In a Phase 3 trial, 70% of patients showed an overall response by Day 28.
The therapy, developed by Mesoblast, is derived from bone marrow cells and works by inhibiting T cell activation and reducing inflammation.
Common side effects include infections, fever, and hypertension.
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La FDA de los EE.UU. aprueba Ryoncil para tratar una condición grave en los niños post-trasplante.