European Medicines Agency recommended 104 medicines for approval in 2025
Esme Needham | January 20, 2026 | News story | Research and Development |Â Â European Medicines Agency, Rare DiseasesÂ
The European Medicines Agency (EMA) has announced data from 2025 showing that over the course of the year it recommended a total of 104 medicines for approval, 38 of which contained a new active substance never before authorised in the EU.
A variety of these medicines were thought to represent an important contribution to public health, including:
• the first medicine for non-cystic fibrosis bronchiectasis
• a treatment to delay onset of stage 3 type 1 diabetes in both adults and children
• the first oral medicine for the treatment of postpartum depression.
The EMA also recommended 16 rare disease treatments for approval, including the first-ever treatment for Wiskott-Aldrich syndrome (WAS). WAS is a rare hereditary immune disease that mainly affects male patients. Another was a gene therapy for dystrophic epidermolysis bullosa, a rare condition that makes skin fragile and susceptible to wounds. The treatment can be applied directly to the affected skin as a topical gel.
The EMA adopted three positive opinions for the use of certain medicines outside the EU. These included a pre-exposure prophylaxis (PrEP) medicine that, in combination with safer sex practices, is intended to lessen the risk of sexually acquired HIV-1 in both adults and adolescents. The medicine is administered subcutaneously twice a year and could be a significant driver in the uptake of PrEP.
Approval recommendations for 41 biosimilars – designed to be interchangeable with reference products and consequently improve treatment access and affordability – were also issued by the EMA in 2025.
Once a treatment has been authorised by the European Commission (EC) and prescribed for patients, its quality, benefits and risks are monitored by both the EMA and EU member states. If needed, these bodies can take regulatory measures after approval, such as recall, withdrawal or suspension of a medicine, or changes to its product information. The EMA’s 2025 overview also features important safety recommendations.
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