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Mesoblast Receives Complete Response From U S Food and Drug Administration for Biologics License Application for Steroid-Refractory Acute Graft Versus Host Disease in Children

Mesoblast Receives Complete Response From U S Food and Drug Administration for Biologics License Application for Steroid-Refractory Acute Graft Versus Host Disease in Children
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United statesSteve dabkowskiPaul hughesSilviu itescuWorldwide network for bloodAustralian securities exchangeDrug administrationInternational consortiumMarrow transplantation groupMarrow transplant researchMesoblast limited nasdaqCorporate communications investorsWhile the oncologic drugs advisory committeeMesoblast the companyInternational bloodBiologics license application

Mesoblast Limited (MESO) Receives CRL from FDA for Steroid-Refractory Acute Graft Versus Host Disease in Children

Mesoblast Limited (MESO) Receives CRL from FDA for Steroid-Refractory Acute Graft Versus Host Disease in Children
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United statesSilviu itescuPaul hughesSteve dabkowskiMesoblast limited nasdaqAustralian securities exchangeInternational consortiumCorporate communications investorsDrug administrationMarrow transplant researchMarrow transplantation groupInternational bloodMesoblast the companyWorldwide network for bloodWhile the oncologic drugs advisory committeeMesoblast limited

FDA Schedules Pre-License Inspection of Remestemcel-L

Biologics License Application (BLA) Resubmission for Pediatric Acute Graft-Versus-Host Disease (SR-aGVHD) Currently Being Reviewed PDUFA Goal Date.

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 consortiumBiologics license application

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