The US Food and Drug Administration (FDA) has approved denosumab-bnht (Conexxence/Bomyntra), manufactured by Fresenius Kabi, for all indications of the reference ...

The study explores whether Prolia/Xgeva (denosumab), a widely used therapy for osteoporosis and bone tumors, can regenerate beta cells in patients with early type 1 diabetes.

The Food and Drug Administration has approved Fresenius Kabi's Biologics License Application for the denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht). These ...

Denosumab-bnht (Conexxence/Bomyntra, Fresenius Kabi) received FDA approval based on findings from two comparative clinical studies. One study assessed the pharmacokinetics, pharmacodynamics and ...

The approval concerns Fresenius Kabi's Conexxence and Bomyntra denosumab biosimilars. The German healthcare company said Wednesday that Fresenius Kabi reached a global settlement with Amgen ...

March 27, 2025--(BUSINESS WIRE)--Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence ® (denosumab-bnht) and Bomyntra ® (denosumab-bnht ...

The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news ...

The FDA approved Bomyntra (denosumab-bnht) to prevent skeletal-related events in adult patients with multiple myeloma and bone metastases from solid tumors. The FDA also approved it to treat ...

LAKE ZURICH, IL, USA I March 27, 2025 I Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence ® (denosumab-bnht) and Bomyntra ® (denosumab-bnht) of ...

Number 5: Biosimilar natalizumab demonstrated comparable efficacy, safety, and immunogenicity to reference drug Tysabri in patients with relapsing-remitting multiple sclerosis (RRMS), supporting its ...

Bomyntra ® (denosumab-bnht) is approved for use to prevent skeletal-related events in adult patients with multiple myeloma and bone metastases from solid tumors. It is also used to treat hypercalcemia ...