Amgen (NASDAQ: AMGN) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the indication for XGEVA® (denosumab ...
Celltrion has received permission from the Food and Drug Administration for Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo), biosimilars referencing Prolia (denosumab) and ...
BRIDGEWATER, N.J., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced ...
Richter and Hikma have received the green light from the Food and Drug Administration for their biosimilar denosumab products, Enoby (denosumab-qbde) and Xtrenbo (denosumab-qbde), referencing Prolia ...
BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, and mAbxience ...
The Food and Drug Administration (FDA) has approved Osvyrti ® (denosumab-desu), a biosimilar to Prolia ® (denosumab), and Jubereq ® (denosumab-desu), a biosimilar to Xgeva ® (denosumab). Osvyrti is ...
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