来自MSN23 小时
Banned Words at FDA; Top Cancer Center Halts DEI Initiatives; 'End Childhood Cancer'
"Woman," "elderly," and "disabled" were among a list of banned words reportedly circulating within the FDA, which the White ...
centerforbiosimilars2 天
EC Approves Celltrion Denosumab, Aflibercept Biosimilars
Celltrion expands its reach in Europe, securing marketing authorization from the European Commission (EC) for its denosumab biosimilar candidate (Stoboclo and Osenvelt) and its aflibercept biosimilar ...
Cancer Therapy Advisor3 天
FDA Approves Denosumab Biosimilars Ospomyv and Xbryk
The FDA has approved the biologics license applications for Ospomyv and Xbryk, biosimilars to Prolia and Xgeva, respectively.
来自MSN4 天
Osteoporosis Biosimilar OK'd; New Endo Guidelines; A Hot Spot for Stealing Ozempic
The FDA approved the denosumab biosimilar Ospomyv, interchangeable with Prolia, for preventing osteoporosis-related fracture ...
Pharm Exec4 天
FDA Approves Samsung Bioepis Biosimilars Ospomyv and Xbryk
Ospomyv, a biosimilar to Prolia, is indicated for postmenopausal women and men at high risk of fracture, while Xbryk, a ...
JD Supra4 天
Regulatory Updates on Samsung’s Denosumab Biosimilars
On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) ...
Ospomyv 和 Xbryk 已获 FDA 批准，分别用于 Prolia 和 Xgeva 的所有适应症
Xbryk（Xgeva）已被批准用于预防多发性骨髓瘤患者和实体瘤骨转移患者的骨骼相关事件、治疗无法切除或手术切除可能导致严重发病率的骨巨细胞瘤成人和骨骼成熟的青少年患者，以及治疗对双膦酸盐疗法有抵抗力的恶性肿瘤高钙血症。
centerforbiosimilars5 天
FDA, EMA Approve Second Pair of Denosumab Biosimilars
The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' ...
Healio5 天
FDA approves two new biosimilars of denosumab
The FDA has approved two new biosimilars of denosumab-dssb to treat osteoporosis, increase bone mass, prevent ...
The Pharma Letter5 天
FDA and EMA green light Samsung Bioepis’ Prolia and Xgeva copies
South Korean biosimilars company Samsung Bioepis has announced that the US Food and Drug Administration (FDA) and European ...
Managed Healthcare Executive5 天
FDA Approves Second Biosimilars for Prolia/Xgeva
Samsung Bioepis’ biosimilars Ospomyv and Xbryk have been approved to be interchangeable with Prolia/Xgeva treat osteoporosis and multiple myeloma/bone metastases from solid tumors.