FDA grants Mesoblast seven years of exclusive approval for drug to treat pediatric patients

From GlobeNewswire: 2025-05-14 22:57:00

Mesoblast has received 7 years of FDA approval for its drug Ryoncil® to treat pediatric patients with steroid-refractory acute graft versus host disease (SR-aGvHD). This exclusive approval prevents approval of similar products for this indication until 2036. Mesoblast also holds biologic exclusivity until 2036. The company is a leader in developing allogeneic cellular medicines to treat inflammatory diseases and has a strong global intellectual property position. Mesoblast is committed to developing cell therapies for various indications and has established commercial partnerships in multiple countries. The company’s proprietary manufacturing processes produce off-the-shelf cellular medicines with defined release criteria.



Read more at GlobeNewswire: FDA Provides Seven Years of Orphan-Drug Exclusive Approval