TEVA applications for Prolia biosimilar accepted by FDA, EMA
Decisions by both agencies are expected in the second half of 2025, according to a statement. Denosumab is marketed under the ...
clinicaladvisor.com8 天
FDA Adds Boxed Warning on Denosumab for Patients With Advanced CKD
The Food and Drug Administration (FDA) has added a new boxed warning on the denosumab drug label (brand name: Prolia) to alert clinicians to an increased risk for severe hypocalcemia in patients with ...