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Denosumab News
FDA Approves Jubbonti (denosumab-bddz), an Interchangeable Biosimilar to Prolia
Basel, March 5, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Jubbonti, (denosumab-bbdz), an i...
FDA Approves Wyost (denosumab-bddz), an Interchangeable Biosimilar to Xgeva
Basel, March 5, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Wyost (denosumab-bbdz), an i...
Denosumab Linked to Severe Hypocalcemia in Dialysis-Dependent Seniors
THURSDAY, Jan. 25, 2024 – For female dialysis-dependent patients aged 65 years or older treated for osteoporosis, denosumab is associated with an increased incidence of severe or very severe...
FDA Medwatch Alert: Drug Safety Communication: Prolia (denosumab) - FDA Adds Boxed Warning for Increased Risk of Severe Hypocalcemia in Patients with Advanced Chronic Kidney Disease
January 19, 20204 – Based on a completed FDA review of available information, FDA has concluded that the osteoporosis medicine Prolia (denosumab) increases the risk of severe hypocalcemia, very low...
Industry Payments to Doctors Tied to Nonrecommended, Low-Value Drug Use
FRIDAY, Oct. 27, 2023 – Industry payments to physicians are associated with nonrecommended and low-value drugs, according to a study published online Oct. 25 in The BMJ. Aaron P. Mitchell, M.D.,...
FDA Approves Prolia (denosumab) for Glucocorticoid-Induced Osteoporosis
THOUSAND OAKS, Calif., May 21, 2018 /PRNewswire/ – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the use of Prolia (denosumab) for the treatment...
FDA Approves Xgeva (denosumab) for the Prevention of Skeletal-Related Events in Patients with Multiple Myeloma
THOUSAND OAKS, Calif., Jan. 5, 2018 /PRNewswire/ – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application...
FDA Approves Xgeva (denosumab) for Hypercalcemia of Malignancy Refractory to Bisphosphonate Therapy
THOUSAND OAKS, Calif., Dec. 8, 2014 /PRNewswire/ – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Xgeva (denosumab) for the...
FDA Approves Xgeva to Treat Giant Cell Tumor of the Bone
June 13, 2013 – The U.S. Food and Drug Administration today expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and...
FDA Approves New Indications for Prolia (denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy
THOUSAND OAKS, Calif., September 19, 2011, 2011 /PRNewswire/ – Amgen today announced that the U.S. Food and Drug Administration (FDA) approved two new indications for Prolia (denosumab) as a...
FDA Approves Amgen's Xgeva (denosumab) for the Prevention of Skeletal-Related Events in Patients with Bone Metastases from Solid Tumors
THOUSAND OAKS, Calif., Nov. 18, 2010 /PRNewswire-FirstCall/ – Amgen Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Xgeva (denosumab), the first and only RANK...
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