Clinical Advisor

FDA Approves Teva’s Prolia Biosimilar Ponlimsi, Accepts Xolair Biosimilar for Review

Alongside the approval of Ponlimsi, the FDA is reviewing a BLA for TEV-45779, a biosimilar candidate for Xolair, covering all currently approved indications.
FierceBiotech

FDA Approves Amgen's Prolia(TM) (Denosumab) for Treatment of Postmenopausal Women With Osteoporosis at High Risk for Fracture

Given As An Injection Every Six Months, Prolia Reduced Risk Of Fracture At The Spine, Hip And Other Sites THOUSAND OAKS, Calif., June 1, 2010 /PRNewswire via COMTEX/ --Amgen Inc. (Nasdaq: AMGN) today ...
MedPage Today

Calcium Levels Quickly Become Critical for Many Denosumab-Treated Women on Dialysis

Many women on dialysis quickly developed severe hypocalcemia after starting denosumab (Prolia) for osteoporosis, Medicare data showed. During the first 12 weeks of treatment, 41.1% of women on ...
FierceBiotech

PROLIA® (DENOSUMAB) GRANTED MARKETING AUTHORIZATION IN THE EUROPEAN UNION

Given as an Injection Every Six Months, Prolia Reduced the Risk of Fractures in Treatment of Postmenopausal Osteoporosis in Women at Increased Risk of Fractures First and Only Approved Treatment in ...