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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 level of ....
Alyssa Matuszak's daughter has received two bone marrow transplants. Now, the mother is advocating for others alongside the National Marrow Donor Program. ....
The first patient has been enrolled in a clinical trial evaluating a reduced dose of post-transplant immunosuppressive chemotherapy cyclophosphamide for patients with blood cancers. ....