Selected EMA news, November 2025

New medicines recommended for approval

• Waskyra (autologous CD34+ hematopoietic stem cells transduced ex vivo with a lentiviral vector encoding human Wiskott-Aldrich syndrome protein)  
  Treatment of Wiskott-Aldrich syndrome (an inherited disease affecting blood cells and cells of the immune system, the body’s natural defenses) 

New information on approved medicines 

• Minjuvi (tafasitamab) – new indication 
  Treatment of large B-cell lymphoma (cancer of white blood cells) 
• Veyvondi (vonicog alfa) – extension of indication 
  Prevention and treatment of bleeding in patients with Willebrand disease (an inherited bleeding disorder) 

Direct Healthcare Professional Communication (DHPC) 

• Lenalidomide Mylan (lenalidomide) 
  Treatment of multiple myeloma (cancer of the bone marrow) 

Supply shortage 

• Beriglobin
  Replacement therapy for adults and children who lack immunoglobulins and are at risk of infection. This includes people with chronic lymphocytic leukemia or multiple myeloma who have hypogammaglobulinemia and recurrent bacterial infections, as well as people who are undergoing or have undergone an allogeneic hematopoietic stem cell transplant and have hypogammaglobulinemia.