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FDA Approves First in Class FcRn Blocker IMAAVY (Nipocalimab aahu) for Warm Autoimmune Hemolytic Anemia
On August 24, 2026, the U.S. Food and Drug Administration approved Janssen Biotech’s IMAAVY (nipocalimab-aahu) injection for adult and pediatric patients aged 12 years and older currently or previously treated with corticosteroids (1,2). This landmark decision represents the first therapy proven safe and effective specifically for warm autoimmune hemolytic anaemia (wAIHA). As a first-in-class treatment, IMAAVY offers clinical management for an underserved community that has h

Dr. Manisha Dadlani
1 day ago5 min read
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