The European Medicines Agency's human medicines committee recommended twelve new medicines for approval in September. These recommendations included innovative treatments for various conditions such as prophylaxis, generalized myasthenia gravis, and active moderate to severe disease. One rabies vaccine was also recommended for pre-exposure and post-exposure prophylaxis. Additionally, the committee positively recommended a new biosimilar medicine for asthma and chronic rhinosinusitis, as well as another for breast cancer treatment. Several new generic medicines received positive recommendations, including treatments for rheumatoid arthritis and myelofibrosis. The committee also initiated re-examinations for certain medicines for acute pain in children and specific cancer types. However, some applications were refused or withdrawn, and the outcomes of certain re-examinations were noted. Extensions of therapeutic indications were recommended for numerous existing medicines across various disease areas. Finally, the committee concluded reviews for ipidacrine-containing products and sodium oxybate for alcohol dependence.