Six new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended six medicines for approval at its January 2026 meeting.

The committee recommended granting a marketing authorisation for Fylrevy (estetrol), a hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women. During menopause, the amount of oestrogen produced by a woman’s body drops. This can cause symptoms such as a hot face, neck and chest, also known as ‘hot flushes’. This medicine is indicated to alleviate these symptoms.

Ilumira (lutetium (¹⁷⁷Lu) chloride), a radiopharmaceutical precursor, received a positive opinion from the CHMP. Ilumira must be used only for the radiolabelling of carrier medicines that have been specifically developed and authorised for radiolabelling with lutetium chloride.

The committee recommended granting a conditional marketing authorisation for Kayshild (semaglutide), a GLP1 receptor agonist for the treatment of non-cirrhotic…