Tad Carter

2020 / 14 August

AADCOM Votes 9:1 in favor of full FDA approval!

BREAKING NEWS: U.S. FDA Oncologic Drugs Advisory Committee voted nine to one in favor of Mesoblast’s remestemcel-L (Ryoncil™) for efficacy in children with steroid-refractory acute graft versus host disease (SR-aGVHD).

This is an important milestone for allogenic cell therapies being developed to treat critical inflammatory diseases, including #COVID19.

RYONCIL has been accepted for Priority Review by the FDA with an action date of September 30, 2020, under the Prescription Drug User Fee Act (PDUFA). If approved, Mesoblast plans to launch RYONCIL in the United States in 2020.

Comments are closed.