Mesoblast’s Cell Therapy For Pediatric GVHD Gets US Panel Green Light Despite FDA's "Substantial Concerns"
Oncologic Drugs Advisory Committee votes 8-2 that data support efficacy of the product, which could be the first mesenchymal stem cell product to clear the agency. FDA's concerns include reliance on a pivotal Phase III single-arm study.
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The announcement of a positive clinical trial and an intention to proceed to a regulatory submission are causes for a company’s investors to rejoice. Sometimes that can be premature.
The Australian company's off-the-shelf cell therapy fell foul of the US FDA for graft-versus-host disease recently but Novartis is backing remestemcel-L as a potential treatment for acute respiratory distress syndrome.
Keeping Track: Disappointment For Mesoblast And Aquestive; Opdivo/Yervoy Add Mesothelioma Claim; Pediatric Approvals
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.