The European Medicines Agency recommended 104 human medicines and 30 veterinary medicines for approval in 2025, according to its annual report released in June. Of the human medicines, 38 contained new active substances never before authorized in the European Union, and 16 were for rare diseases.
Among the notable approvals were Rezdiffra, the first EU-authorized treatment for metabolic dysfunction-associated steatohepatitis (MASH); Yeytuo (lenacapavir), a twice-yearly injectable for HIV pre-exposure prophylaxis; Zurzuvae, the first oral medicine for postpartum depression; and Vimkunya, a Chikungunya vaccine for adolescents and adults from 12 years of age.
On the veterinary side, the 30 recommendations marked the highest number for a second consecutive year. Thirteen contained new active substances, and 16 were vaccines — including seven approved under exceptional circumstances to respond to animal health emergencies such as the serotype-3 bluetongue virus.
The report also highlighted EMA’s expanding use of real-world data. Its Data Analysis and Real-World Interrogation Network (DARWIN EU) grew to 33 data partners across 16 countries, covering roughly 180 million patients, and conducted 67 studies. In July, EMA published its first AI Observatory Report, and the agency jointly developed ten guiding principles for AI in medicine development with the FDA.
The year carried symbolic weight as well: 2025 marked EMA’s 30th anniversary, the 25th anniversary of the EU Orphan Regulation, and the 20th anniversary of the SME Regulation. EMA’s SME Office has helped small and medium-sized enterprises bring innovative medicines to market since 2005.
The agency officially launched the EU Medicines Agencies Network Strategy to 2028, and its European Shortages Monitoring Platform became operational in January, enabling direct reporting of supply and demand information during crises. The Executive Steering Group on Shortages and Safety of Medicinal Products managed several critical shortages over the year, including GLP-1 receptor agonists.
EMA closed 2025 with 1,035 staff and total revenue of EUR 607.56 million, a 21% increase from 2024.
Source: EMA News
