Mesoblast 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. …read more
Source:: Yahoo Finance
