FDA Schedules Pre-License Inspection of Remestemcel-L Manufacturing
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FDA Accepts Mesoblast’s Resubmission of the Biologic License Application for Remestemcel-L In…
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DREAM-HF Phase 3 Trial Results for Mesoblast Cell Therapy in Heart Failure Published in Journal of…
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FDA Grants Regenerative Medicine Advanced Therapy (Rmat) Designation for Rexlemestrocel-L in Chronic…
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Children Treated With Remestemcel-L Show Long-Term Survival Through Four Years in Steroid-Refractory…
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 children and 25-38% in recently published studies…
Mesoblast Submits New Information to FDA IND File in Response to Items in the CRL to the…
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 submitted to the U.S. Food and Drug…
Rexlemestrocel-L to be Highlighted at Maxim’s Panel on Late-Stage Advancements in Heart Failure…
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 rexlemestrocel-L, its allogeneic “off-the-shelf” product…
Appendix 4C Quarterly Activity Report
NEW YORK, April 28, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the third quarter ended March 31,…
Rapid Improvement and Remission in Patients With Refractory Ulcerative Colitis and Crohn’s Colitis…
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 results from an interim analysis of the first…
Mesoblast Provides Update Following Meeting With FDA’s OTAT on Remestemcel-L for Children With Acute…
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 (CMC) items identified in the complete response…