https://www.pharmalive.com/fda-action-alert-aquestive-eton-and-me...

https://www.pharmalive.com/fda-action-alert-aquestive-eton-and-mesoblast/

Australia’s Mesoblast Limited has a target action date of September 30 for Ryoncil (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGVHD) in children. On August 13, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted “overwhelmingly” in favor of the efficacy of the drug in pediatric patients. Although the FDA is not required to follow the advisory committee’s recommendation, it often does.

“Steroid-refractory acute graft versus host disease is an area of extreme need, especially in vulnerable children under 12 years old where there is no approved therapy,” said Fred Grossman, the company’s chief medical officer, in a statement at the time. “We are very encouraged by today’s outcome and are committed to working closely with the FDA as they complete their review of our submission regarding approval of Ryoncil for this life-threatening complication of an allogeneic bone marrow transplant.”