South Korea-based Celltrion today announced that the US Food and Drug Administration (FDA) has approved Stoboclo and Osenvelt ...
The U.S. Food and Drug Administration (FDA) has approved Celltrion’s Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, ...
Amneal Pharmaceuticals (AMRX) “announced that the FDA has accepted for review its Biologics Licensing Application for two proposed denosumab ...
Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved STOBOCLO® (CT-P41, denosumab-bmwo) ...
(Nasdaq: AMRX) ("Amneal" or the "Company"), a global biopharmaceutical company, and mAbxience ("mAbxience") today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its ...
The FDA has approved two new biosimilars of denosumab-dssb to treat osteoporosis, increase bone mass, prevent skeletal-related events for people with multiple myeloma and other indications, Samsung ...
Women with osteoporosis have at least a 50% chance of reaching their target bone mineral density at 3 years if they have a ...
Clinical studies confirmed equivalent efficacy, safety, and pharmacokinetics between denosumab biosimilars and reference products. Common adverse events for Ospomyv include back pain and ...
The FDA has approved the BLA for Ospomyv™ and Xbryk™, biosimilars to Prolia (denosumab) and Xgeva (denosumab), respectively.
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 ...
Celltrion today announced that the European Commission (EC) has granted marketing authorization for three products across two biosimilars: Eydenzelt® ...
Findings from a phase 3 trial showed denosumab-dssb had comparable efficacy, safety, immunogenicity, PK and PD to Prolia in patients with postmenopausal osteoporosis. Ospomyv is approved to treat ...
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