The European Medicines Agency (EMA) recommended 14 new medicines for approval in September 2025. These recommendations stemmed from the Committee for Medicinal Products for Human Use (CHMP) meeting. Four new medicines received positive opinions. Several new biosimilar medicines, including those based on denosumab, were also recommended. A new generic medicine, rivaroxaban, was given the green light. CHMP also positively recommended extensions of therapeutic indications for existing drugs. Several applications for initial marketing authorization were withdrawn. Some applications were re-examined by the committee. The EMA also provided updates on the use of Lutathera and other pharmaceutical inquiries. Additionally, updates were provided for previously approved medicines like Lunsumio and Norvir.