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.

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

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

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

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 ...

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

Fresenius’ operating company Fresenius Kabi reached a global settlement with Amgen concerning their denosumab biosimilars, allowing launch in the U.S. in mid-2025 and in Europe later in H2 of ...

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 ...

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 has approved Fresenius Kabi Biopharma's denosumab biosimilars, Conexxence and Bomyntra (denosumab-bnht), for all indications of the reference products Prolia and Xgeva, respectively, further ...

Conexxence ® (denosumab-bnht) is approved for use in various adult patient populations at high risk for fractures, including those with osteoporosis, individuals undergoing certain cancer treatments ...

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 ...