The approval was based on a comprehensive clinical data package, which included a single phase 1 trial and a phase 3 trial.

City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States and a top ...

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Researchers predicted the likelihood of achieving target T-scores in postmenopausal women with osteoporosis who received denosumab therapy for 10 years.

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 FDA approved denosumab-bmwo for all indications of the reference drugs Prolia and Xgeva. According to a settlement between Amgen and Celltrion, the biosimilars can be launched as early as June 1.

Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the ...

Amneal announced FDA acceptance of its Biologics License Application (BLA) for two proposed denosumab biosimilars ...

After approval by the FDA, AVT03 is expected to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 ml ...

Currently, Amneal commercializes three biosimilars in the U.S., with the two denosumab biosimilar candidates representing its next potential biosimilar launches. Additionally, three more ...

During the trial, scientists from City of Hope ® will assess if people with early type 1 diabetes can protect and preserve ...

The study included 2 treatment periods. During the first period, study participants (N=479) were randomly assigned 1:1 to receive denosumab-bmwo or the reference product. Patients who received the ...