In 2022, the European Medicines Agency (EMA) recommended 89 medicines for market registration, of which 41 contained a new active substance that has not yet been approved in the EU.[1][2][4][5] Key statistics include 8 PRIME-designated drugs, 21 orphan drugs, 8 biosimilars, and 6 advanced therapy drugs.[1][2] The report highlights drugs representing significant advances in therapeutic areas, such as Mounjaro to improve blood sugar control in type II diabetes, Xenpozyme as the first treatment for acid sphingomyelinase deficiency (ASMD), and Zokinvy as the first treatment for progeroid syndromes in children.[1] In neurology, Upstaza is the first gene therapy for AADC deficiency in adults and children.[1] Beyfortus is the first medicine to prevent lower respiratory tract disease caused by RSV in newborns and infants in the first season of risk.[1] In 2022, product information for 467 centrally approved drugs was updated based on new safety data.[2][5] The EMA continued to monitor the safety of medicines and issued recommendations on vaccines and treatments for COVID-19 and monkeypox.[3][4]