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 ...
In another first, Sandoz launched in November 2025 the first FDA-approved biosimilar of Tysabri (natalizumab). Tyruko (natalizumab-sztn) is used to treat adult patients with relapsing multiple ...
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 ...
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 ...
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, ...
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 ...
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 ...
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 ...
"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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