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Sanofi announced that the FDA granted Breakthrough Therapy designation to rilzabrutinib (Wayrilz) for warm autoimmune hemolytic anemia (wAIHA), and Japan's Ministry of Health, Labour and Welfare granted orphan drug designation for the same indication, based on Phase 2b LUMINA 2 study data. These designations aim to expedite development and review for this rare autoimmune disorder with no approved targeted treatments.