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Oncologic Drugs Advisory Committee Vote

The FDA's Oncologic Drugs Advisory Committee voted in favor of remestemcel-L's efficacy for pediatric steroid-refractory aGVHD.

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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...