Mesoblast hit by FDA rejection, request to run another trial

Mesoblast hit by FDA rejection, request to run another trial

Source: 
Fierce Biotech
snippet: 

The FDA has issued  a complete response letter to Mesoblast’s request for approval of allogeneic cell therapy remestemcel-L in children with steroid-resistant graft-versus-host disease. FDA officials want to see data from at least one additional clinical trial before granting full authorization, but Mesoblast is still hoping to snag an accelerated approval using its existing data.

Mesoblast hit by FDA rejection, request to run another trial