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 ...

--Amgen today announced new data from a real-world study of nearly half of a million postmenopausal women with osteoporosis in the U.S. medicare program showing Prolia ® injection reduced fracture ...

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 ...

The Food and Drug Administration (FDA) has approved Stoboclo ® (denosumab-bmwo), a biosimilar to Prolia ® (denosumab), and Osenvelt ® (denosumab-bmwo), a biosimilar to Xgeva ® (denosumab). Stoboclo is ...

The US Food and Drug Administration (FDA) has added a boxed warning to the label of the osteoporosis drug denosumab (Prolia) about increased risk for severe hypocalcemia in patients with advanced ...

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 ...

BENGALURU, India and BRIDGEWATER, N.J., Sept. 17, 2025 /PRNewswire/ -- Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of ...

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 ...

The researchers found that with denosumab vs oral bisphosphonates, the risk for emergently treated hypocalcemia increased with worsening CKD stage. (HealthDay News) — For patients with chronic kidney ...