Amgen (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) approved a new indication for Prolia® (denosumab) as a treatment to increase bone mass in men with osteoporosis at high ...
This month, Samsung Bioepis announced the European launch of Obodence (60 mg pre-filled syringe) and Xbryk (120 mg vial), ...
Our news journalists obtained a quote from the research from Optum, "Potential denosumab 60 mg off-label use was observed based on claims, but many had evidence of on-label indications based on ...
REYKJAVIK, ICELAND (September 22, 2024) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today ...
In the extension, all subjects, regardless of original randomization, received open-label Prolia (60 mg) every six months. The long-term group received up to 10 years of Prolia (three years in the ...
FDA’s boxed warning on denosumab follows study results showing increased and early risks of severe hypocalcemia in patients on dialysis. The Food and Drug Administration (FDA) has added a new boxed ...
Please provide your email address to receive an email when new articles are posted on . Denosumab is a monoclonal antibody inhibitor of receptor activator of nuclear factor kappa B ligand that ...
INCHEON, Korea, February 15, 2025--(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 ...