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DASEA's 3D-Bioengineered Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes Successfully Obtain Dual CBER & CDER Filings from US FDA

作者：REGEN-αGEEK

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2025-01-09

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On January 7, 2025, REGEN-αGEEK kicked off the new year with major news: its human umbilical cord mesenchymal stem cell-derived exosomes, prepared using the self-developed DASEA Bio-manufacturing Platform with 3D cultivation, have successfully obtained dual Drug Master File (DMF) filings with both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) under the US Food and Drug Administration (FDA).


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