Here is our regular summary of content of relevance to neurology from the Human Medicines Highlights – February 2026
Key EMA News Updates:
- EMA Executive Director reflects on 2025 achievements
Emer Cooke shares an end-of-year message highlighting key accomplishments in medicine regulation throughout 2025 and outlines future directions. Click here for more details: Emer Cooke, EMA’s Executive Director: 2025 achievements in medicine regulation | European Medicines Agency (EMA) - EMA Management Board meeting highlights
The Board welcomed the political agreement on the new EU pharmaceutical legislation and adopted EMA’s work programme for 2026. Click here for more details: EMA Management Board: highlights of December 2025 meeting | European Medicines Agency (EMA) - EMA and FDA agree on principles for AI in medicine development
The two agencies set out common principles to guide responsible use of artificial intelligence in generating evidence and monitoring medicines across their lifecycle. Click here for more details: EMA and FDA set common principles for AI in medicine development | European Medicines Agency (EMA) - Review started for Tavneos (avacopan)
EMA has initiated a review of the medicine Tavneos for rare autoimmune diseases following concerns about the integrity of data supporting its authorisation. Click here for more details: EMA starts review of Tavneos, a medicine for rare autoimmune diseases GPA and MPA | European Medicines Agency (EMA) - New episode of Inside EMA podcast on medicine shortages
Episode 3 focuses on challenges in managing medicine shortages and the collaborative work with national authorities. Click here for more details: Podcast: Inside EMA | European Medicines Agency (EMA)
Medicines
- New medicines recommended for approval – Kygevvi– On 29 January 2026, the Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation under exceptional circumstances for the medicinal product Kygevvi (doxecitine/doxribtimine), intended for the treatment of adults and children with genetically confirmed thymidine kinase 2 deficiency (TK2d) with an age of symptom onset at or before 12 years. Click here for more details: Kygevvi | European Medicines Agency (EMA)
