FDA Schedules Pre-License Inspection of Remestemcel-L Manufacturing
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FDA Accepts Mesoblast’s Resubmission of the Biologic License Application for…
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DREAM-HF Phase 3 Trial Results for Mesoblast Cell Therapy in Heart Failure Published…
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FDA Grants Regenerative Medicine Advanced Therapy (Rmat) Designation for…
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Children Treated With Remestemcel-L Show Long-Term Survival Through Four Years in…
Key Points: Long-term survival evident through 4 years in children treated with remestemcel-L in Phase 3 trial MSB-GVHD001Overall survival at 2 years was 51% in remestemcel-L treated…
Mesoblast Submits New Information to FDA IND File in Response to Items in the CRL to…
NEW YORK, Oct. 02, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that it has…
Rexlemestrocel-L to be Highlighted at Maxim’s Panel on Late-Stage Advancements in…
NEW YORK, July 11, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that…
Rapid Improvement and Remission in Patients With Refractory Ulcerative Colitis and…
NEW YORK, Feb. 20, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced positive…
Mesoblast Provides Update Following Meeting With FDA’s OTAT on Remestemcel-L for…
Key Points: Meeting held with the US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) to address potency assay and chemistry, manufacturing and controls…
FDA’s OTAT in Agreement With 12-Month Reduction in Pain as Primary Endpoint for…
NEW YORK, Dec. 15, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has…