Amneal Announces FDA Approval of Denosumab Biosimilars Referencing Prolia® and XGEVA®

Approvals expand Amneal’s biosimilars portfolioCompany expects to commercialize six biosimilars across eight presentations by 2027 BRIDGEWATER, N.J., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Amneal ...
Benzinga.com

Amgen's Blockbuster Osteoporosis Drug Prolia Flagged With FDA Strictest Warning

The FDA has added a serious warning to the prescribing information for Amgen Inc’s (NASDAQ:AMGN) drug Prolia (denosumab), emphasizing an increased risk of severely low calcium levels in specific ...
Managed Healthcare Executive

Biosimilars in 2025: A year of firsts

In another first, Sandoz launched in November 2025 the first FDA-approved biosimilar of Tysabri (natalizumab). Tyruko (natalizumab-sztn) is used to treat adult patients with relapsing multiple ...
Medscape

Drug Combo Boosts Bone Health in Postmenopausal Osteoporosis

Adding romosozumab to ongoing denosumab treatment shows increased lumbar spine bone mineral density with preserved anabolic ...
Yahoo

US FDA adds 'boxed warning' for Amgen's bone loss drug Prolia

An Amgen sign is seen at the company's office in South San Francisco (Reuters) - The U.S. Food and Drug Administration added a serious warning on the prescribing information for Amgen's drug Prolia to ...
Medscape

Lower Diabetes Risk Linked to Osteoporosis Drug Denosumab

Continued denosumab treatment is associated with a lower risk for diabetes in adults with osteoporosis older than 65 years, found a large-scale cohort study in Taiwan. Denosumab, used in osteoporosis ...
Monthly Prescribing Reference

FDA Adds Boxed Warning to Prolia Label Regarding Hypocalcemia Risk in CKD

Findings showed treatment with Prolia significantly increased the risk of developing severe hypocalcemia compared with bisphosphonates, especially in patients with advanced CKD. In patients with ...
Healio

Denosumab bests alendronate as first-line therapy for fracture prevention in osteoporosis

Please provide your email address to receive an email when new articles are posted on . Denosumab as a first-line osteoporosis therapy is linked to lower fracture risks than alendronate among ...
Seeking Alpha

Amgen osteoporosis drug Prolia outperforms commonly used therapy

Amgen (NASDAQ:AMGN) announced new data supporting its FDA-approved osteoporosis therapy Prolia (Denosumab) on Monday, highlighting its potential against oral alendronate, a commonly-used medication to ...
MedPage Today

Denosumab Protective Against Diabetes?

Continued treatment with the osteoporosis drug denosumab (Prolia) was tied to a lower risk of developing diabetes in a Taiwanese cohort study. In a propensity score-matched analysis, adherence to ...
Healio

FDA investigates risk of hypocalcemia for patients on dialysis using Prolia

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 ...

Mabxience And Amneal Announces FDA Approval Of Denosumab Biosimilars Referencing Prolia® And XGEVA®

Mabxience And Amneal Announces FDA Approval Of Denosumab Biosimilars Referencing Prolia® And XGEVA®. mAbxience / Key word(s): Miscellaneous mAbxience and Amneal Announces FDA Approval of Denosumab ...