After Almost 4 Years, FDA Says Mesoblast Phase 3 Therapy Data Can Support Resubmission For Serious Complications in Children Following Stem Cell Transplant
Monday, the FDA informed Mesoblast Limited (NASDAQ:MESO) that following additional consideration, the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed Biologics License Application (BLA) for remestemcel-L for pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD). “We thank the agency for their collaborative approach. The responses and guidance from FDA are clear and provide us with a high le...
Silviu Itescu International Blood While The Oncologic Drugs Advisory Committee Mesoblast Limited Marrow Transplant Research Biologics License Application
Source: yahoo.com