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See important safety & full prescribing information. The fda evaluated libtayo under priority review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in the treatment of serious conditions. The fda evaluated libtayo under priority review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in the treatment of serious conditions

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An additional regulatory application is also under review in the european union, with a decision expected by the first half of 2026. Review important safety info & full prescribing information including med guide. Libtayo fda approval history last updated by judith stewart, bpharm on oct 9, 2025

Yes (first approved september 28, 2018) brand name

Listen to the fda d.i.s.c.o Podcast about this approval on sept