Tag: Mesoblast

United States Food & Drug Administration (FDA) Supports Accelerated Approval Pathway for Rexlemestrocel-L in End-Stage Heart Failure Patients with a Left Ventricular Assist Device (LVAD)

NEW YORK, March 10, 2024 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA supports an accelerated approval pathway for rexlemestrocel-L, Mesoblast’s allogeneic mesenchymal precursor cell (MPC) product, […]

United States Food & Drug Administration (FDA) Grants Mesoblast Rare Pediatric Disease Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease

REVASCOR Increases Size of Left Heart Chamber and Improves Surgical Outcomes in Children with Hypoplastic Left Heart Syndrome: Results Published in Journal of Thoracic and Cardiovascular Surgery Open NEW YORK, Jan. 18, 2024 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), […]

Mesoblast Files for Orphan Drug and Pediatric Rare Disease Designations for Rexlemestrocel-L as Treatment for Severe Congenital Heart Disease

NEW YORK, Nov. 26, 2023 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has filed for orphan drug designation (ODD) and rare pediatric disease designation (RPDD) with the […]

DREAM-HF Phase 3 Trial Results for Mesoblast Cell Therapy in Heart Failure Published in Journal of the American College of Cardiology (JACC)

Single Intra-Myocardial Intervention with Rexlemestrocel-L Reduced Cardiovascular Death, Myocardial Infarction or Stroke Over Mean Follow-Up of 30 Months in High-Risk Patients with Chronic Heart Failure NEW YORK, Feb. 27, 2023 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic […]

Rexlemestrocel-L to be Highlighted at Maxim’s Panel on Late-Stage Advancements in Heart Failure Therapeutics and Management

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 candidate for the treatment of chronic heart failure (CHF) with reduced […]