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Upadacitinib is approved by the FDA and EMA for the treatment of rheumatoid arthritis (RA). The FDA and EMA approvals apply to a dose of 15 mg/day in adults with moderate to severe active rheumatoid arthritis who have had an inadequate response to or are intolerant of at least one disease-modifying antirheumatic drug (DMARD). Both agencies granted these approvals based on robust efficacy and safety data from the SELECT Phase 3 study program, which showed significant benefits in RA patients both as monotherapy and in combination with conventional DMARDs (1, 2, 3).