Remestemcel L

The FDA announced several regulatory actions the past few weeks.

The FDA issued a complete response letter to a biologics license application that seeks approval of remestemcel-L to treat certain children with graft-versus-host disease.

An FDA advisory committee voted 9-1 in favor of approval of the cell therapy remestemcel-L for the treatment of children with steroid-refractory acute graft-versus-host disease.

The FDA granted priority review to the allogeneic cell therapy remestemcel-L for the treatment of children with steroid-refractory acute graft-versus-host disease, according to the agent’s manufacturer.