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Reported Late Tuesday March 7, FDA Accepts Mesoblast’s Resubmission Of The Biologic License Application For Remestemcel-L In Children With Steroid-Refractory Acute Graft Versus Host Disease As A Complete Response And Sets Goal Date Of August 2, 2023

By Happy Mohamed
Today, 9:07 PM
Mesoblast Limited (NASDAQ:MESO, ASX:MSB)))), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration's (FDA) Office of Therapeutic

MESO

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1 minute read

FDA Granted Mesoblast Regenerative Medicine Advanced Therapy Designation granted For Rexlemestrocel-L In Chronic Low Back Pain

By Charles Gross
Today, 9:07 PM
Mesoblast Limited (ASX:MSB; Nasdaq:MESO) today announced that the United States Food and Drug Administration's (FDA) Office of Tissues and Advanced Therapies (OTAT) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for rexlemestrocel-L in the treatment of chronic low back pain (CLBP) associated with disc degeneration, in combination with hyaluronic acid (HA) as delivery agent

MESO

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5 minute read

Mesoblast Says Resumbits Biologic License Application To FDA For Remestemcel-L In Children With With Steroid-Refractory Acute Graft Versus Host Disease (Sr-aGVHD)

By Michael Horton
Today, 9:07 PM
Validation of Remestemcel-L Potency Assay used in the Phase 3 Trial which Measures In-Vivo Activity based on Mechanism of Action Assay Identifies High-Potency Product Lots Associated with Enhanced Survival New Data Show that Remestemcel-L Improves Inflammatory Biomarkers and Survival in Children at Highest Risk of Mortality

MESO

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1 minute read

Mesoblast and Oaktree Extend Availability Period of Undrawn Tranches of Financing Facility

By Charles Gross
Today, 9:07 PM
Mesoblast Limited (NASDAQ:MESO, ASX:MSB))), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that funds managed by Oaktree Capital Management, L.P. ("Oaktree") have extended to Mesoblast the availability of up to an additional US$30.0 million of its US$90 million five year facility subject to achieving certain milestones on or before September 30, 2023.

MESO