Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, and Pakistan's The Searle Company Limited (PSX: SEARL, hereinafter "Searle") jointly announced that two ...

Shanghai Henlius Biotech and Organon have received permission from the Food and Drug Administration for Bildyos ...

Prolia is an injection given every 6 months to treat osteoporosis in men, postmenopausal women, and people who take corticosteroid medicines who are at high risk for fractures.

Bildyos and Bilprevda have the same indications as the reference products Prolia and Xgeva and are expected to be available later this year.

The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation (CDSCO) has recommended ...

Henlius and Organon receive FDA approval for biosimilar denosumab injections Bildyos and Bilprevda. Read more here.

Amgen announced that the FDA approved a new indication for Prolia (denosumab injection) as a treatment to increase bone mass in men with osteoporosis at high risk for fracture.

Prolia, which is given by injection once every six months, works to decrease the destruction of bone and increase bone mass and strength by inhibiting proteins that activate bone-destroying cells.

Xgeva is a high dose of the denosumab injection, which Amgen also markets in a lower dose as skeleton-building drug Prolia. With the panel tipping its cards on Xgeva pre-tumor use, analysts skewed ...

FDA’s boxed warning on denosumab follows study results showing increased and early risks of severe hypocalcemia in patients on dialysis.

SAN DIEGO — Romosozumab is superior to denosumab for increasing bone mineral density in the spine at 12 months among chronic glucocorticoid users with osteoporosis at high fracture risk ...

US FDA approves Henlius & Organon’s Bildyos and Bilprevda, biosimilars to Prolia and Xgeva respectively: Shanghai, China Wednesday, September 3, 2025, 12:00 Hrs [IST] Shanghai H ...