Johnson & Johnson’s Imaavy (immunoglobulin?—as provided: antibody drug) gained an FDA label expansion to treat warm autoimmune hemolytic anemia (wAIHA), becoming the first FDA-approved therapy specifically indicated for the rare condition. J&J positioned the monoclonal antibody as potentially scalable across hematology by extending beyond its initial myasthenia gravis approval. The update follows earlier approval for generalized myasthenia gravis and underscores how developers are building multi-indication strategies around antibody platforms. With wAIHA, the company is expanding into a setting where durable efficacy and manageable safety are central to adoption. The new approval also strengthens the broader debate on how quickly payers and clinicians will transition from traditional immunosuppression to targeted antibody options in autoimmune hemolysis.