Mesoblast Submits Clinical Efficacy and Safety Data to FDA in Rolling Biologics License Application for Remestemcel-l

Mesoblast Submits Clinical Efficacy and Safety Data to FDA in Rolling Biologics License Application for Remestemcel-lMesoblast Limited (Nasdaq: MESO) announced that the United States Food and Drug Administration (US FDA) has confirmed receipt of Mesoblast’s filing of clinical efficacy and safety data for remestemcel-L in its rolling Biologics License Application (BLA) for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). The final module will be filed during January, and Mesoblast will request an expedited FDA review of the BLA under the product candidate’s existing Fast Track designation.



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