14 new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its September 2025 meeting.

The committee recommended granting a marketing authorisation for Enflonsia (clesrovimab), a medicine indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants. RSV is a common respiratory virus that usually causes symptoms similar to the common cold but can also affect the lungs. Almost all children get an RSV infection by the time they are two years old. While most recover quickly, in some children RSV can cause severe illness that may lead to hospitalisation and even death.

The CHMP recommended granting a marketing authorisation for Imaavy (nipocalimab), for the treatment of generalised myasthenia gravis, a disease that leads to muscle weakness and tiredness.

A positive opinion was adopted for Kyinsu (insulin icodec / semaglutide), for the treatment of adults with type 2…