ARTICLE | Product Development
Nearly a decade after Japanese approval, mesenchymal stromal cell therapy approved for pediatric GvHD
By Meredith Durkin Wolfe, Director of Research
December 20, 2024 2:31 AM UTC
At long last, Mesoblast has gained its first FDA approval — nearly a decade after Japan’s regulatory agency approved the same product, an allogeneic bone marrow-derived mesenchymal stromal cell therapy for GvHD.
On Thursday, after multiple regulatory setbacks over the years, Ryoncil remestemcel-L gained approval by the U.S. agency to treat steroid-refractory acute graft-versus-host disease in pediatric patients. Approval of the product from Australian regenerative medicine company Mesoblast Ltd. (ASX:MSB; NASDAQ:MESO) marks the first mesenchymal stromal cell (MSC) therapy approved by FDA…
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- Source: https://www.biocentury.com/article/654533/long-awaited-fda-approval-for-mesoblast-marks-a-first-in-the-u-s