--Amgen today announced new data from a real-world study of nearly half of a million postmenopausal women with osteoporosis in the U.S. medicare program showing Prolia ® injection reduced fracture ...

Denosumab is indicated for treating osteoporosis in postmenopausal women, preventing skeletal-related complications in cancer ...

(Reuters) - Amgen Inc, the world's largest biotechnology company, said U.S. health regulators approved its Prolia injection for a new use as a treatment to increase bone mass in men with osteoporosis ...

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 ...

Credit: Fresenius Kabi. Conexxence and Bomyntra were approved by the FDA in March 2025. The interchangeability designation allows the biosimilars to be substituted for the reference product at the ...

MADRID, Dec. 22, 2025 /PRNewswire/ -- mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, and Amneal Pharmaceuticals, Inc. ("Amneal" or the "Company") (NASDAQ: ...

As Sandoz gears up to launch one of the most anticipated biosimilars of the year, the company could face near-term competition thanks to a new agreement between Amgen and Celltrion. Late last week, ...

NEW YORK (Reuters) - The U.S. Food and Drug Administration approved on Tuesday the sale of Amgen Inc's osteoporosis drug Prolia to help prevent fractures in post-menopausal women just days after 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 ...

Findings showed denosumab-qbde demonstrated comparable quality, efficacy, safety, and immunogenicity to the reference product. Enoby is approved to treat postmenopausal women with osteoporosis at high ...