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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 ...
centerforbiosimilars1d
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 Advisor2d
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.
Pharm Exec3d
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 Supra3d
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) ...
centerforbiosimilars4d
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' ...
Healio4d
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 Letter4d
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 Executive4d
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.
Business Wire5d
Samsung Bioepis Gains European Commission (EC) Approval for Denosumab Biosimilar (OBODENCE™, XBRYK™)
Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for OBODENCE™ (60mg pre-filled syringe ...
Business Wire6d
FDA Approves Samsung Bioepis’ OSPOMYV™, XBRYK™ (denosumab-dssb), a Biosimilar to Prolia and Xgeva
INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for OSPOMYV™ (denosumab ...