Latest batch of new meds backed for approval by EMA/CHMP

The European Medicines Agency’s EMA) human medicines committee (CHMP) recommended four novel medicines for approval at its September 2025 meeting.

The committee recommended granting a marketing authorization for Merck & Co’s (NYSE: MRK) – known as MSD in Europe – 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.