Managed Healthcare Executive5h
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 ...
Healio7d
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, ...
Medscape7d
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 Executive7d
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, ...
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 Kabi, has ...
JD Supra7d
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), ...
Targeted Oncology2d
FDA Oncology Actions: March 2025 Approvals and Designations
On March 5, 2025, the FDA cleared an investigational new drug application for CTD402, a CD7-targeted universal CAR T-cell ...
Drug Store News8d
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 ...