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 ...
Business Insider

European Commission Approves Prolia® (denosumab) for Patients With Glucocorticoid-Induced Osteoporosis

The U.S. Food and Drug Administration (FDA) approved the expanded indication of Prolia for the treatment of osteoporosis associated with newly initiating or sustained systemic glucocorticoid therapy ...
FiercePharma

FDA approves new indication for Prolia® (Denosumab) for the treatment of bone loss in men with osteoporosis at high risk for fracture

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 ...
manilatimes

Celltrion receives U.S. FDA approval for STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) biosimilars referencing PROLIA® and XGEVA®

JERSEY CITY, N.J., March 4, 2025 /PRNewswire/ -- Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved STOBOCLO ® (CT-P41, denosumab-bmwo) and OSENVELT ® (CT-P41, ...
Drug Store News

Sandoz receives FDA approval for Prolia, Xgeva biosimilars

Sandoz has obtained the Food and Drug Administration’s clearance for Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), the only FDA-approved denosumab biosimilars, to treat all indications of ...
Drug Store News

Celltrion receives FDA nod for Prolia, Xgeva biosimilars

Celltrion has received permission from the Food and Drug Administration for Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo), biosimilars referencing Prolia (denosumab) and ...
Healio

Cyclic teriparatide, denosumab administration benefits cortical BMD in osteoporosis

Postmenopausal women with osteoporosis who received a regimen of three separate, 6-month cycles of daily teriparatide followed by one subcutaneous injection of denosumab experienced a moderate gain in ...
FiercePharma

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

THOUSAND OAKS, Calif., June 1 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Prolia ...
Medscape

FDA Alert: 'Substantial' Hypocalcemia Risk with Prolia Use in Dialysis Patients

The US Food and Drug Administration (FDA) issued an alert today that cited preliminary evidence for a "substantial risk" for severe and symptomatic hypocalcemia and serious outcomes related to ...

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 ...

Amneal Pharmaceuticals, Inc.: 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 Pharmaceu ...