5 February 2026
The European Medicines Agency has published statistics on human medicines approval from the past year. The full report can be accessed here.
New approval recommendations
In 2025, 104 new medicines were recommended for marketing authorisation with 38 of these having new active substances not previously authorised in the Union. These numbers are slightly lower than in the previous year, when 114 new medicines were recommended, 46 of which contained new active substances. The approvals span a range of therapeutic areas, with notable new products targeting diabetes, pulmonary disease and post-partum depression. Compared to 2024, a higher proportion of biosimilar products were approved (41 compared to 28) however, 23 of these were for the same molecule (denosumab).
In the area rare diseases, 16 new products were recommended for approval. These recommendations cover various therapeutic areas such as cancer, dermatology, haematology, immunology, metabolic diseases, and neurology. They include, for example, a gene therapy designed to treat a very severe skin condition. Cancer remains the leading area for rare disease approval recommendations, but it is encouraging to see growing attention being given to other therapeutic fields as well.
Extension recommendations
In addition to the recommendations for new approvals there were also 89 recommendations for extension of the indication for already approved products, including 40 recommendations for paediatric use. Most of the paediatric recommendations were based on results from the studies conducted under the agreed paediatric investigation plan, making them a natural part of the product’s overall lifecycle.
Safety recommendations
The report also included information on safety recommendations for authorised products. Several new recommendations were issued during 2025, including for example: enhanced measures to minimise the risk of suicidal thoughts in patients taking finasteride or dutasteride for the treatment of androgenetic alopecia, removal of certain indications for azitromycin in order to minimize the risk for antimicrobial resistance and an update to include non-arteritic anterior ischemic optic neuropathy (NAION) as a very rare side effect in the product information for semaglutide. These key safety‑related updates conclude the highlights from this year’s review.
Rolf Eriksson
PhD, Senior Expert Regulatory Affairs
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