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Romosozumab, sold under the brand name Evenity (/ ɪ ˈ v ɛ n ɪ t i / ih-VENN-ih-tee or with the pin-pen merger, / ɪ ˈ v ɪ n ɪ t i / ih-VINN-ih-tee), is a medication used to treat osteoporosis. [ 7 ] [ 8 ] It has been found to decrease the risk of fractures of the spine .
2019: In January, Evenity (romosozumab) received approval in Japan, [76] [77] followed by FDA approval in April. [78] In June, Kanjinti (trastuzumab-anns) was approved by the FDA. [79] Amgen announced it would acquire Nuevolution AB for 1.61 billion Swedish crowns ($166.8 million) to enhance its drug discovery capabilities. [80]
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The FDA approved Samsung Bioepis Co., Ltd.'s Renflexis (infliximab-abda) in April 2017. [1] Biogen released another biosimilar, Flixabi, which was approved in Germany, the UK, and the Netherlands. [62] Flixabi was approved for use in the European Union in May 2016. [5] In December 2017, Ixifi (infliximab-qbtx) was approved in the United States. [4]
The EC grants marketing authorization to Amgen (AMGN) and partner UCB's Evenity for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.
The CHMP provides an unfavorable feedback to Amgen's (AMGN) marketing application for Evenity to treat severe osteoporosis in postmenopausal women with risk of fracture.
Repatha was approved by the FDA in August. [44] Add to end of "2015" bullet: In October, the FDA approved Imlygic. [45] Add to end of "2016" bullet: Also in September, the FDA approved Amjevita (adalimumab-atto). [46] Add to end of "2017" bullet: The FDA approved Parsabiv in February [47] and Mvasi (bevacizumab-awwb) in September. [48]
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