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Home » FDA Denies Mesoblast’s Ryoncil Despite Advisory Committee Recommendation
FDA Denies Mesoblast’s Ryoncil Despite Advisory Committee Recommendation
The FDA has hit Mesoblast’s biologics license application (BLA) for Ryoncil (remestemcel-L) with a complete response letter despite a strong vote by the agency’s expert advisory committee vote in favor of the stem cell treatment for pediatric steroid-refractory acute graft vs. host disease.