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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 level of ....

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Medical Non-Compliance Post-BMT in Pediatric Patients Associated With Annual Income, Insurance Status

The study results also indicated that graft versus host disease status was associated with non-compliance following bone marrow transplantation. ....

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Trial Evaluates Reduced Chemo Post-Stem Cell Transplant in Blood Cancers

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. ....

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