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FDA Approves Fresenius’s Denosumab Biosimilars

On March 26, 2025, the FDA approved Fresenius Kabi’s denosumab biosimilars, CONEXXENCE® (denosumab-bnht) and BOMYNTRA® (denosumab-bnht), referencing Amgen’s PROLIA® and XGEVA®, respectively.  These approvals make Fresenius...more

Acuitas Sues GSK Seeking Declaratory Judgment of Invalidity and Non-Infringement of mRNA Vaccine Patents

​​​​​​​As we previously reported, in April of last year, GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC brought a lawsuit against Pfizer and BioNTech in the District Court for the District of Delaware, alleging that...more

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