13 new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended 13 medicines for approval at its June 2025 meeting.

The committee recommended granting a marketing authorisation for Austedo (deutetrabenazine), for the treatment of adults with moderate-to-severe tardive dyskinesia, a disorder in which predisposed patients experience abnormal involuntary movements resulting from chronic or even episodic exposure to dopamine receptor antagonists.

Imreplys (sargramostim) received a positive opinion from the CHMP for a marketing authorisation under exceptional circumstances for the treatment of people with haematopoietic acute radiation syndrome, when the bone marrow produces fewer blood cells leading to a higher risk of infection and bleeding, following acute exposure to radiation.   

A positive opinion was adopted for Ogsiveo* (nirogacestat), for the treatment of adults with progressing desmoid tumours, a type of soft tissue tumours that form in fibrous…