The FDA on January 21, 2025, approved GRAFAPEX®, an alkylating agent, with Fludarabine as a preparative regimen, for allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with Acute Myeloid Leukemia (AML) or MyeloDysplastic Syndrome (MDS). GRAFAPEX® is a product of medac GmbH.
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