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Jan 17, 2017
US FDA accepts Mylan’s BLA for proposed trastuzumab product Biocon and Mylan have announced acceptance of the latter’s biologics licence application (BLA) by the US Food and Drug Administration (FDA) for MYL-1401O, a proposed biosimilar trastuzumab. Mylan’s MYL-1401O is indicated to treat certain HER2-positive breas...
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