Mesoblast Limited's Ryoncil (remestemcel-L) is in on track to be the second product approved for treatment of pediatric steroid-refractory acute graft-versus-host disease in the United States and the first mesenchymal stem cell (MSC) therapy to clear the US Food and Drug Administration. But a citizen petition for an unnamed party argues that the trial data is inadequate and urges the agency to require an additional study before granting licensure.
Scott Lassman, of Lassman Law+Policy, submitted the citizen petition on 20 July, and in response to a query said...