Ten new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its November 2025 meeting.

The committee recommended granting a marketing authorisation for Dawnzera (donidalorsen), for the routine prevention of recurrent attacks of hereditary angioedema (swelling) in adults and adolescents aged 12 years and older. Patients with hereditary angioedema have attacks of rapid swelling such as in the face, throat, arms and legs, or around the gut.

The CHMP recommended granting a marketing authorisation for GalenVita (germanium (⁶⁸Ge) chloride / gallium (⁶⁸Ga) chloride), a radionuclide generator. GalenVita is used to produce 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) received a positive opinion from the CHMP for the treatment of adults with locally advanced or metastatic…