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FDA Approves Nipocalimab as First Treatment for Warm Autoimmune Hemolytic Anemia

August 25, 2026

Source Summary

The FDA has approved nipocalimab (Imaavy) as the first treatment for warm autoimmune hemolytic anemia (wAIHA), the most common form of autoimmune hemolytic anemia. Nipocalimab is an immunoselective neonatal Fc receptor (FcRn) blocker.

Why it matters

This approval provides the first FDA-authorized treatment option for patients with warm autoimmune hemolytic anemia, a previously untreated condition.

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