Green light for 10 new medicines in November 2025

The European Medicines Agency’s key committee on human medicines (CHMP) recommended ten medicines for approval at its November 2025 meeting. This brings to 97 the total number of products given the green light this year.

The committee recommended that the European Commission, which must now sign off on the advice, grant authorisation to the following products:

• Dawnzera (donidalorsen), for the routine prevention of recurrent attacks of hereditary angioedema (swelling) in adults and adolescents aged 12 years and older.
• GalenVita (germanium (68Ge) chloride / gallium (68Ga) chloride), a radionuclide generator. GalenVita produces gallium (68Ga) chloride solution, that is used to label carrier molecules used for positron emission tomography (PET) diagnostic imaging of different types of tumours.
• Inluriyo (imlunestrant) for the treatment of adults with locally advanced or metastatic breast cancer with a specific mutation in the gene ESR1.
• Teizeild (teplizumab), a first-in-class treatment to delay the onset of stage 3 type 1 diabetes in adults and in children from eight years of age with stage 2 type 1 diabetes.
• Vacpertagen (acellular pertussis vaccine), a vaccine used to prevent pertussis, often called whooping cough, a highly infectious disease that can occur at any age.
• Waskyra (etuvetidigene autotemcel),the first gene therapy to treat Wiskott-Aldrich syndrome, a rare, inherited disease, seen almost exclusively in males, that affects blood cells and cells of the immune system.
• Enzalutamide Accordpharma (enzalutamide) for the treatment of prostate cancer.

The committee adopted positive opinions for two biosimilar medicines: Ondibta (insulin glargine), for the treatment of diabetes mellitus; and Osqay (denosumab), for the treatment of osteoporosis and bone loss.

A generic medicine, Teduglutide Viatris (teduglutide), was approved for the treatment of short bowel syndrome, a condition in which nutrients and fluids are not properly absorbed by the gut, usually because a large part of the intestine has been surgically removed.

The committee recommended extensions of indication for four medicines that are already authorised in the EU: Koselugo, Minjuvi, Veyvondi and Xerava.