SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) said it has submitted a supplemental Biologics License Application to the ...

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 ...

Data from the pivotal ENERGY trial showed IMAAVY® produced a rapid and durable hemoglobin responsea in wAIHA Currently no FDA-approved therapies are available for wAIHA ...

/ -- Autoimmune hemolytic anemia (AIHA) treatment encompasses a range of therapeutic strategies aimed at mitigating the immune system's attack on red blood cells, thereby alleviating anemia and ...

Paris, February 9, 2026. The US Food and Drug Administration (FDA) has granted a designation as breakthrough therapy to Wayrilz (rilzabrutinib), a novel oral, reversible Bruton’s tyrosine kinase (BTK) ...

(RTTNews) - HUTCHMED (China) Ltd. (HCM) on Wednesday announced that Phase III registration part of its ESLIM-02 clinical trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic ...

Sanofi’s rilzabrutinib earns orphan drug designation in Japan for IgG4-related disease Designation based on positive data from a phase 2 study of ...

Dr. Florence H. Porterfield (Medicine): A 71-year-old woman was admitted to this hospital because of refractory hemolytic anemia. The patient, who had recurrent breast cancer and diffuse cutaneous ...

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 ...

Sanofi's rilzabrutinib designated breakthrough therapy in the US and orphan drug in Japan for the treatment of warm autoimmune hemolytic anemia Rilzabrutinib is the first and only investigational BTKi ...