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FDA Issues CRL to BLA Resubmission for Remestemcel-L in Pediatric Steroid-Refractory aGVHD

The FDA has released a complete response letter to its biologics license application resubmission, indicating that it needs more data to support approval for remestemcel-L for the treatment of pediatric patients with steroid-refractory acute graft-vs-host disease.
United States Silviu Itescu International Consortium Marrow Transplant Research Oncologic Drugs Advisory Committee International Blood

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