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Denosumab, a drug commonly used to treat osteoporosis and prevent bone complications in cancer patients, is being investigated for a potential new application in breast cancer treatment. Early results ...

Dialysis patients on denosumab (Prolia, Xgeva) had a lower risk for fracture but higher risk for a certain heart event, suggested an observational trial weighted to emulate a clinical trial.

HyClone Laboratories, LLC (“HyClone”) filed a Motion to Quash in the U.S. District Court for the District of Utah, seeking to ...

Biocon Biologics Ltd (“BBL”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive ...

FDA committee recommends Amgen's denosumab, for the treatment, but not prevention, of bone loss, while Lilly decides not to submit arzoxifene for regulatory review after 5-year trial. Later this ...

Novartis' soon-to-be-divested Sandoz unit has positive clinical trial data in hand for a biosimilar of Amgen's blockbuster osteoporosis therapy Prolia (denosumab), clearing the way for regulatory ...

Sandoz has claimed the first FDA approvals for biosimilars of Amgen’s blockbuster bone disease therapy denosumab, but has not said when it plans to launch them onto the US market. Amgen sells ...