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Mesoblast Launches FDA-Approved Ryoncil for Pediatric Graft Versus Host Disease

Mesoblast Launches FDA-Approved Ryoncil for Pediatric Graft Versus Host Disease

Mesoblast, a global leader in allogeneic cellular medicines for inflammatory diseases, has announced the commercial launch of Ryoncil (remestemcel-L-rknd) in the United States for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged two months and older.

Ryoncil is currently the only mesenchymal stromal cell (MSC) therapy approved by the US Food and Drug Administration (FDA). The launch was spotlighted last week during presentations at the Morgan Stanley and Cantor Fitzgerald Annual Global Healthcare Conferences in New York.

Mesoblast Chief Executive Dr. Silviu Itescu highlighted the strong first-quarter performance of Ryoncil, as recently reported in the company’s full-year earnings, and emphasised ongoing efforts to onboard new sites and increase product usage.

Additionally, Dr. Itescu announced the company’s plans to expand Ryoncil’s use into additional indications, including adult SR-aGvHD and biologic-resistant inflammatory bowel disease (IBD).

Key Phase 3 milestones are also expected for its second-generation product, Rexlemestrocel-L, which is being developed for heart failure and chronic low back pain.

Mesoblast continues to advance its allogeneic stromal cell technology platforms to address severe inflammatory conditions, supported by commercial partnerships in Japan, Europe, and China. The company also maintains a robust global intellectual property portfolio, with more than 1,000 granted patents and applications providing commercial protection through at least 2041 in major markets.

More news about: global pharma | Published by Dineshwori | September - 15 - 2025 | 142

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