Postmenopausal women with osteoporosis who received a regimen of three separate, 6-month cycles of daily teriparatide followed by one subcutaneous injection of denosumab experienced a moderate gain in ...

The U.S. Food and Drug Administration (FDA) approved the expanded indication of Prolia for the treatment of osteoporosis associated with newly initiating or sustained systemic glucocorticoid therapy ...

Amgen (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) approved a new indication for Prolia® (denosumab) as a treatment to increase bone mass in men with osteoporosis at high ...

Findings showed treatment with Prolia significantly increased the risk of developing severe hypocalcemia compared with bisphosphonates, especially in patients with advanced CKD. In patients with ...

THOUSAND OAKS, Calif., June 1 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Prolia ...

“In a hypothetical health plan covering 1 million lives, adding biosimilar denosumab to a health plan formulary may contribute to significant cost savings; savings can be reinvested to further expand ...

JERSEY CITY, N.J., March 4, 2025 /PRNewswire/ -- Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved STOBOCLO ® (CT-P41, denosumab-bmwo) and OSENVELT ® (CT-P41, ...

The US Food and Drug Administration (FDA) issued an alert today that cited preliminary evidence for a "substantial risk" for severe and symptomatic hypocalcemia and serious outcomes related to ...

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 ...

Amgen's bone-bulking drugs Xgeva and Prolia are winning market share from Novartis' (NVS) Zometa. Expanding across indications Xgeva and Prolia are different doses of the drug denosumab. They work by ...

INCHEON, Korea, February 15, 2025--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for ...