US FDA requests further data on remestemcel-L before approving it for the treatment of paediatric steroid-refractory graft versus host disease (GVHD)

The Oncologic Drugs Advisory Committee voted 9:1 that the available data support its efficacy, but the FDA recommends that the company conduct at least one additional RCT in adults and/or children to provide further evidence of its effectiveness.

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Biospace Inc.