AUSTIN, Texas – Denosumab (Prolia, Xgeva) carried no increased risk of cardiovascular disease or stroke when compared with zoledronic acid (Reclast, Zometa) to combat osteoporosis, researchers found.
The U.S. Food and Drug Administration (FDA) has issued a black box warning — reserved for the most serious safety issues — for the osteoporosis drug denosumab, sold under the brand name Prolia.
Denosumab (Prolia, Xgeva) treatment for postmenopausal women with osteoporosis may increase the risk of dental issues, researchers reported, though they were mostly minor. According to 10-year data ...
Please provide your email address to receive an email when new articles are posted on . The FDA is investigating the risk of severe hypocalcemia in patients on dialysis treated with the osteoporosis ...
Please provide your email address to receive an email when new articles are posted on . Samsung Bioepis received approval for two biosimilars of denosumab that are interchangeable with Prolia and ...
New 2-Year Open-Label Study Shows More Than 90 Percent of Patients Preferred Prolia Injection Every Six Months Over Weekly Oral Alendronate THOUSAND OAKS, Calif., March 23, 2011 /PRNewswire/ -- Amgen ...
THOUSAND OAKS, Calif., June 1, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced results from a randomized, double-blind, placebo-controlled, multicenter Phase 3 study evaluating the treatment ...
Wyost and Jubbonti were approved as interchangeable biosimilars for Xgeva and Prolia; however, there is no launch date yet pending litigation with the maker of the reference products. Wyost and ...
INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for OSPOMYV™ (denosumab ...
The biosimilars revolution continues with the U.S. FDA’s approval of the first denosumab biosimilars: Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz) from Sandoz Inc. for treating osteoporosis ...
Original Medicare (Part A and Part B), Part D, and Medicare Advantage typically offer coverage for the osteoporosis drug Prolia. However, individuals must meet certain requirements for Part B coverage ...
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