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Mesoblast Resubmits Biologic License Application (BLA) to FDA for Remestemcel-L in Children With Steroid-Refractory Acute Graft Versus Host Disease (Sr-aGVHD)

Mesoblast Resubmits Biologic License Application (BLA) to FDA for Remestemcel-L in Children With Steroid-Refractory Acute Graft Versus Host Disease (Sr-aGVHD)
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United States , Silviu Itescu , Steve Dabkowski , Paul Hughes , Marrow Transplant Research , Drug Administration , International Blood , Australian Securities Exchange , Marrow Transplantation Group , Oncologic Drugs Advisory Committee , Mesoblast Limited Nasdaq , Corporate Communications Investors , Worldwide Network For Blood , Mount Sinai Acute Gvhd International Consortium , Remestemcell Potency Assay , Measures In Vivo Activity , Identifies High Potency Product Lots Associated , Data Show , Remestemcell Improves Inflammatory Biomarkers , Highest Risk , Year Data , Shows Durable Long Term Survival Outcomes , Preview Period , First Treatment Available , Children Under , Devastating Disease ,

Mesoblast Resubmits Biologic License Application (BLA) to

Validation of Remestemcel-L Potency Assay used in the Phase 3 Trial which Measures In-Vivo Activity based on Mechanism of Action Assay Identifies. ....

United States , Silviu Itescu , Steve Dabkowski , Paul Hughes , Marrow Transplant Research , Drug Administration , International Blood , Australian Securities Exchange , Marrow Transplantation Group , Oncologic Drugs Advisory Committee , Mesoblast Limited Nasdaq , Corporate Communications Investors , Worldwide Network For Blood , Mount Sinai Acute Gvhd International Consortium , Remestemcell Potency Assay , Measures In Vivo Activity , Identifies High Potency Product Lots Associated , Data Show , Remestemcell Improves Inflammatory Biomarkers , Highest Risk , Year Data , Shows Durable Long Term Survival Outcomes , Preview Period , First Treatment Available , Children Under , Devastating Disease ,