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Mesoblast's remestemcel-L (Ryoncil) FDA Approval

Mesoblast's interactions with the FDA regarding the approval of remestemcel-L (Ryoncil) for pediatric steroid-refractory aGVHD, including the submission of additional data and the FDA's requests for confirmatory evidence.

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Jan 19, 2026

What were the FDA’s concerns in Mesoblast’s prior complete response letters and how were they addressed for pediatric aGVHD approval?

The FDA’s earlier complete response letters (CRLs) for Mesoblast’s remestemcel‑L (Ryoncil) centered on two buckets of concern: the adequacy of clinical evidence—specifically a preference for randomize...