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This is the second rejection for remestemcel-L, after the FDA first turned down Mesoblast’s application in 2020, despite a 9-1 advisory committee vote in its favor

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Die Einbeziehung der Analyse auf bakterielle Endotoxine in das umfassendere Testprogramm liefert den Forschern zusätzliche chargenspezifische analytische Informationen über das getestete Forschungsmaterial