www.ema.europa.eu EMA has published an overview of its key recommendations of 2025 regarding the authorisation and safety monitoring of veterinary medicines. In 2025, EMA recommended 30 veterinary medicines for marketing authorisation - the highest number of recommendations ever in a year...

www.ema.europa.eu CVMP opinions on veterinary medicinal products The Committee adopted a positive opinion on a marketing authorisation from Elanco for Lotilaner / Milbemycin Elanco (lotilaner / milbemycin oxime), for use in dogs with, or at risk from, mixed infestations/infections by ticks,...

www.ema.europa.eu At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and...

www.ema.europa.eu In 2025, EMA recommended 104 medicines for marketing authorisation. Of these, 38 had a new active substance which had never been authorised in the European Union (EU) before. This includes medicines representing important innovation or contribution to public health, such...

www.ema.europa.eu The use of AI technologies across the medicines lifecycle has increased significantly in recent years. As emphasised in the European Commission’s Biotech Act proposal, AI holds great promise as a tool to accelerate the path from innovation to safe and effective medicines....