Amgen wants to extend use of bone cancer drug Xgeva (denosumab) into the prevention setting, but analysts, not to mention the FDA’s own advisors, are not optimistic about its chances of securing the ...
The Food and Drug Administration (FDA) has approved supplemental Biologics License Applications (sBLA) for Amgen's Prolia (denosumab) and Xgeva (denosumab). The proposed sBLA includes the addition ...
THOUSAND OAKS, Calif., Nov. 18, 2010 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved ...
REYKJAVIK, ICELAND (September 22, 2024) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today ...
SHANGHAI, Dec. 16, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with an integrated industry chain, announced that it has completed the first commercial shipment of ...
FDA Approves Amgen's XGEVA(TM) (Denosumab) for the Prevention of Skeletal-Related Events in Patients with Bone Metastases from Solid Tumors --First Bone Targeted Therapy for Cancer Patients to Be ...
SHANGHAI, Sept. 5, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, and Pakistan's The Searle Company Limited (PSX: SEARL, ...
August 11, 2009 — Denosumab injections are associated with lower fracture rate in postmenopausal women with osteoporosis, according to the results of an international, randomized, double-blind, ...
Amgen (Nasdaq: AMGN) today announced top-line results from a Phase 3 trial evaluating XGEVA(TM) (denosumab) versus placebo in 1,432 men with castrate-resistant prostate cancer. The trial, known as the ...
Organon, a global women’s health company with deep expertise in biosimilar commercialization, has entered into an agreement with Shanghai Henlius Biotech, whereby Organon will license ...
Zoledronate infusion preserves BMD gains after denosumab discontinuation for women with osteoporosis
Please provide your email address to receive an email when new articles are posted on . Discontinuation of denosumab is associated with a rapid return to pretreatment BMD levels and an increased risk ...
"Today's approval of XGEVA illustrates what is possible when scientific innovation, commitment and investment come together to advance medicine," said Kevin Sharer, chairman and chief executive ...
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