Johnson & Johnson’s Imaavy received a US label expansion for warm autoimmune hemolytic anemia (wAIHA), positioning it as the first FDA-approved therapy specifically for the rare autoimmune condition. The antibody drug was originally cleared the prior year for generalized myasthenia gravis. The expansion moves Imaavy closer to multi-indication scale and signals J&J’s broader strategy of building franchise value through antibody reuse across immune-mediated diseases. For clinicians, the decision also provides a new treatment option in wAIHA, where there is ongoing need for targeted, durable disease control. Market participants will watch uptake and real-world prescribing, especially given the overlap of wAIHA management with existing immunosuppressive approaches and the need to define sequencing in clinical practice.