“We thank the agency for their collaborative approach. The responses and guidance from FDA are clear and provide us with a high level of confidence to refile our BLA for remestemcel-L in children with SRaGVHD,” said Mesoblast CEO Dr Silviu Itescu. …
Investors welcome Mesoblast update and pathway for resubmission to FDA
April 3, 2024 Australian Biotech
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