Summary
PISCATAWAY, N.J.–(BUSINESS WIRE)–Kashiv BioSciences, LLC, a fully-integrated biopharmaceutical company, announced that they have submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA), for ADL-018, a proposed biosimilar to XOLAIR (omalizumab). The submissions are intended to seek approval in the United States and the European Economic Area, respectively.
Source: Businesswire
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