FDA Stay Informed RSS
- Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product November 15, 2019FDA has taken another step to further foster biologics competition with the approval of 25th biosimilar, Abrilada (adalimumab - afzb), a biosimilar to Humira.FDA
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- Pfizer's Xeljanz gets EMA blood clots warning following FDA's similar move November 15, 2019European drug regulators have turned a temporary restriction on Pfizer’s Xeljanz into a formal one. Compared with the FDA's "boxed warning," the EMA version puts a smaller restriction on the higher dose but a stronger warning about the drug's use in all patients at high risk of blood clots.Angus Liu