Gedeon Richter Plc. and Hikma Pharmaceuticals Plc. has announced that the U.S. Food and Drug Administration (FDA) had accepted for review the Biologics License Applications (BLA) for RGB-14, a Denosumab biosimilar candidate comprising two biosimilar products referencing Prolia® and Xgeva®, a human monoclonal antibody for the treatment of osteoporosis and fractures due to bone metastasis, […]
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