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submissionacceptance

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FDA Submission Acceptance for Richter Products

D&T
Dec 12, 2024

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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