On 18 January 2019, the FDA approved the Herceptin®-biosimilar Ontruzant® (trastuzumab-dttb, Samsung BioEpsis), a HER2/neu receptor antagonist, for patients with HER2-overexpressing (HER2+) breast cancer in the adjuvant and metastatic setting, and in metastatic HER2+ gastric cancer patients. Ontruzant® was approved as biosimilar, not as an interchangeable product.
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TOKYO and BASKING RIDGE, N.J., October 3, 2018 /PRNewswire/ -- The Japan Ministry of Health, Labour and Welfare (MHLW) granted the Orphan Drug designation to axicabtagene ciloleucel (KTE-C19, Daiichi Sankyo) for the treatment of diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBL), and transformed follicular lymphoma (TFL), which are all aggressive forms of non-Hodgkin lymphoma (NHL).
The Enhanced Recovery after Surgery (ERAS) Society recently published Part 1 of the Society's 3-part caesarean delivery guidelines, focussed on pre-operative care for women undergoing scheduled and unscheduled caesarean delivery, in the American Journal of Obstetrics & Gynecology. Caesarean delivery is the most common surgical procedure in the modern world.
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