Mesoblast plans to immediately start onboarding transplant centers following the US Food and Drug Administration approval of its allogeneic cell therapy Ryoncil (remestemcel-L) for pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD), after it was the subject of two complete response letters (CRL) from the agency.
Mesoblast Finally Gets FDA Nod For Ryoncil
The cell therapy won approval for pediatric steroid-refractory acute graft versus host disease after two complete response letters over the last four years.

More from Cell Therapies
Seeking cell therapy approaches to cure type 1 diabetes, Vertex abandons a candidate encapsulated to avoid immune system detection but hopes to file another candidate for approval in 2026.
Kyoto-based venture moves HQ to California to expand R&D and business outreach for its regulatory T-cell technology, as it raises around $46m in public and private funding.
The promise of innovative therapies seems to have been constrained not by efficacy or safety concerns, but because the high price of treatments is incongruous with the reimbursement of short-course therapies.
Miltenyi’s leadership calls for a streamlined regulatory framework as India gears to scale in cell and gene therapy. Executives from the German group also talked to Scrip about helping advance local capabilities, delivering point-of-care CAR- T cell therapy to hospitals and pricing dynamics.