November EMA/CHMP batch of novel medicines backed for approval
The European Medicines Agency’s EMA’s human medicines committee (CHMP) recommended seven novel medicines for approval at its November 2025 meeting.
The committee recommended granting a marketing authorization for Japanese drugmaker Otsuka’s (TYO: 4578) 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 authorization for GalenVita (germanium (68Ge) chloride/gallium (68Ga) chloride), a radionuclide generator from Curium Romania. 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 tumors.
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