Denosumab-bnht is expected to launch in the US in June 2025 per an agreement with the reference product’s manufacturer, Amgen ...

On March 5, 2025, the FDA cleared an investigational new drug application for CTD402, a CD7-targeted universal CAR T-cell ...

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

The FDA has approved two new denosumab biosimilars that are interchangeable with the reference medications Prolia and Xgeva, ...

The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, ...

Accord Healthcare Limited (Accord) is pleased to announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for ...

On March 26, 2025, the FDA approved Fresenius Kabi’s denosumab biosimilars, CONEXXENCE® (denosumab-bnht) and BOMYNTRA® (denosumab-bnht), ...

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 ...

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

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.

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“The FDA's filing acceptance of Dr. Reddy's proposed denosumab biosimilar marks an important milestone in bringing this biosimilar medication to more patients throughout the U.S.,” said Milan ...