HUTCHMED Announces NDA Acceptance in China with Priority Review Status and Breakthrough Designation for Sovleplenib for the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., April 29, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; ...
MPR

Nipocalimab Under Review for Warm Autoimmune Hemolytic Anemia

If approved, the neonatal Fc receptor blocker would become the first FDA-authorized therapy specifically indicated for patients with wAIHA.
Monthly Prescribing Reference

Rilzabrutinib Gets Breakthrough Status for Warm Autoimmune Hemolytic Anemia

Phase 2b LUMINA 2 study data support rilzabrutinib's FDA Breakthrough Therapy designation for the treatment of warm autoimmune hemolytic anemia. The Food and Drug Administration (FDA) has granted ...

FDA grants Priority Review for IMAAVY® (nipocalimab-aahu) as the potential first approved treatment for people living with warm autoimmune hemolytic anemia (wAIHA)

Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) for IMAAVY® ...
The American Journal of Managed Care

Management of Autoimmune Hemolytic Anemia Needs Improvement, Investigators Say

Additional population-based studies of autoimmune hemolytic anemia and its management are needed to reduce mortality in this patient population. Autoimmune hemolytic anemia (AIHA) is typically a ...
The American Journal of Managed Care

Types of Autoimmune Hemolytic Anemias

Mihir Raval, MD, MPH, comments on the difference between cold agglutinin disease and other autoimmune hemolytic anemias. Neil Minkoff, MD: Now, you had mentioned that there are other autoimmune ...
HealthLeaders Media

ICD-10-CM Coding for Autoimmune Hemolytic Anemia

Cold antibody hemolytic anemia is a rare autoimmune disorder characterized by the premature destruction of red blood cells by autoantibodies at temperatures of approximately 0 to 10 degrees Celsius. Q ...

Johnson & Johnson's Imaavy Gets FDA Priority Review for Rare Blood Disorder

Johnson & Johnson secured fast-track status for its autoimmune drug Imaavy, accelerating the regulatory timeline for what could become the first approved treatment for warm autoimmune hemolytic anemia ...
MedPage Today

Acquired Hemolytic Anemias: Rates and Prevalence May Be Increasing

A data analysis from Denmark is the first to look at frequency of acquired hemolytic anemias from a large population perspective, and it shows an increase in most forms of this disorder. Researchers ...
Medscape

Is This a Hemolytic Transfusion Reaction?

Physical/chemical causes. These causes of hemolysis are most often secondary to improper handling of blood products. Reasons include inadvertent heating or freezing with subsequent thawing of the red ...
Healio

FDA approves Pyrukynd for adults with pyruvate kinase deficiency-related hemolytic anemia

Please provide your email address to receive an email when new articles are posted on . The FDA approved mitapivat for the treatment of hemolytic anemia in adults with pyruvate kinase deficiency.