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Mesoblast scores US regulatory breakthrough – The Australian Financial Review
Mesoblast has scored a win in marketing its stem cell therapy drug in the US after a verdict was delivered about 7am AEST.
A US healthcare Oncologic Drugs Advisory Committee (ODAC) meeting has voted eight to two in favour of a Mesoblast drug to treat transplant rejections in children.
The verdict was delivered about 7am AEST after the US Food and Drug Administration’s (FDA) Advisory Committee majority voted the available clinical data supplied by Mesoblast support the efficacy of its Ryoncil drug in pediatric patients with acute-Graft Versus Host Disease (aGVHD).
The final decision on whether to approve Mesoblast’…
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