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FDA Schedules Pre-License Inspection of Remestemcel-L Manufacturing

FDA Schedules Pre-License Inspection of Remestemcel-L Manufacturing
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United statesLonza bioscienceSilviu itescuSteve dabkowskiPaul hughesMarrow transplant researchDrug administrationInternational bloodAustralian securities exchangeMarrow transplantation groupOncologic drugs advisory committeeCorporate communications investorsWorldwide network for bloodMesoblast limitedMount sinai acute gvhd international consortiumLicense application

FDA Accepts Mesoblast s Resubmission of the Biologic

If Approved, Remestemcel-L will be the First Allogeneic “Off-the-Shelf” Cellular Medicine in the US, and the First Therapy for Children Under 12 Years Old.

United statesSilviu itescuSteve dabkowskiPaul hughesMarrow transplant researchDrug administrationInternational bloodAustralian securities exchangeCompany biologics license applicationMarrow transplantation groupOncologic drugs advisory committeeMesoblast limited nasdaqCorporate communications investorsOffice of therapeutic productsWorldwide network for bloodMount sinai acute gvhd international consortium

Remestemcel-L Clinical and Potency Studies Presented at

NEW YORK, Feb. 16, 2023 (GLOBE NEWSWIRE) Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory.

United statesJoanne kurtzbergSteve dabkowskiPaul hughesMarrow transplant researchDrug administrationInternational bloodAustralian securities exchangeMarrow transplantation groupOncologic drugs advisory committeeDuke university medical centerMesoblast limited nasdaqCorporate communications investorsWorldwide network for bloodMount sinai acute gvhd international consortiumAmerican society

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 statesSilviu itescuSteve dabkowskiPaul hughesMarrow transplant researchDrug administrationInternational bloodAustralian securities exchangeMarrow transplantation groupOncologic drugs advisory committeeMesoblast limited nasdaqCorporate communications investorsWorldwide network for bloodMount sinai acute gvhd international consortiumRemestemcell potency assayMeasures in vivo activity

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 statesSilviu itescuSteve dabkowskiPaul hughesMarrow transplant researchDrug administrationInternational bloodAustralian securities exchangeMarrow transplantation groupOncologic drugs advisory committeeMesoblast limited nasdaqCorporate communications investorsWorldwide network for bloodMount sinai acute gvhd international consortiumRemestemcell potency assayMeasures in vivo activity