Managed Healthcare Executive11d
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, ...
Medscape10d
FDA Approves Fourth Denosumab Biosimilar
Denosumab-bnht is expected to launch in the US in June 2025 per an agreement with the reference product’s manufacturer, Amgen ...
Managed Healthcare Executive3d
New Trial to Investigate Osteoporosis Drug for Type 1 Diabetes
The study explores whether Prolia/Xgeva (denosumab), a widely used therapy for osteoporosis and bone tumors, can regenerate ...
Healio10d
FDA grants approval to two more denosumab biosimilars
The FDA has approved two new denosumab biosimilars that are interchangeable with the reference medications Prolia and Xgeva, ...
PipelineReview.com11d
Fresenius Receives FDA Approval for their Denosumab Biosimilars and Secures Global Settlement Agreement
LAKE ZURICH, IL, USA I March 27, 2025 I Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence® ...
Drug Store News12d
Fresenius receives FDA nod for Prolia, Xgeva biosimilars
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 ...
JD Supra10d
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), ...
Yahoo Finance11d
Fresenius Receives FDA Approval for their Denosumab Biosimilars and Secures Global Settlement Agreement
March 27, 2025--(BUSINESS WIRE)--Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence ® (denosumab-bnht) and Bomyntra ® (denosumab-bnht ...
Joplin Globe12d
Fresenius Receives FDA Approval for their Denosumab Biosimilars and Secures Global Settlement Agreement
Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence ® (denosumab-bnht) and Bomyntra ® (denosumab-bnht) of its operating company Fresenius ...
Fresenius Says FDA Approved Biologics License Application for Bone-Disease Drugs
Fresenius said the U.S. Food and Drug Administration has approved a biologics license application for its operating company's bone-disease drugs. The approval concerns Fresenius Kabi's Conexxence and ...