Trial data showed significant increases in durable hemoglobin responses versus placebo
— Trial data showed significant increases in durable hemoglobin responses versus placebo
by Ian Ingram, Managing Editor, MedPage Today
August 25, 2026
• 2 min read
The FDA approved nipocalimab (Imaavy) as the first treatment for warm autoimmune hemolytic anemia (wAIHA), the most common form of autoimmune hemolytic anemia.
FDA approves IMAAVY® (nipocalimab-aahu) as first-ever treatment for warm autoimmune hemolytic anemia (wAIHA), representing a…
IMAAVY® (nipocalimab-aahu) demonstrates durable hemoglobin response and rapid onset of effect in pivotal Phase 2/3 study in warm…
Johnson & Johnson secured FDA approval for IMAAVY, the first targeted therapy to treat warm autoimmune hemolytic anemia in adults…
J&J's Imaavy approved for warm autoimmune hemolytic anemia; Takeda's Orzeyful & Rhythm's Imcivree approved in Japan; Basking's…
Johnson & Johnson reports Phase 2/3 data showing IMAAVY improved hemoglobin levels in wAIHA patients and secured FDA Priority…
Just 16 months after Johnson & Johnson scored its initial FDA app | Sixteen months after Johnson & Johnson scored its initial FDA…
