US FDA Again Asked To Hold Off On Approval Of Ryoncil Pediatric Cell Therapy

 
• By Brenda Sandburg

Attorney says new information Mesoblast submitted following ‘complete response’ letter does not include data from randomized controlled trial, which he says is needed to provide substantial evidence of efficacy in treatment of children with graft-versus-host disease.

Graft-versus-host disease
Additional study is needed for approval of cell therapy for pediatric graft-versus-host disease, petitioner tells FDA • Source: Shutterstock

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