EMA’s message on GLP-1 medicines: Health, not hype. They are long-term treatments requiring medical supervision, not lifestyle shortcuts.
To counter misuse, we launched the #HealthNotHype campaign in 2025 with creators to promote safe, responsible use.
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A 2025 milestone: EMA recommended the first-ever treatment to delay the onset of stage 3 type 1 diabetes in adults & children.
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In Europe, cardiovascular diseases remain the leading cause of death (with 1.7 million lives lost every year.), disability and early retirement.
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For the 1st half of 2026, we received letters of intent for 84 new marketing authorisation applications, including:
✔️58 new active substances
✔️28 orphan medicines
✔️4 advanced therapies,
setting the stage for another impactful year.
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Last year set a record: we approved 41 biosimilars—the highest number ever. Nearly 40% of all 2023 approvals were biosimilars.
EMA has 20 years of experience with biosimilars, during which we recommended over 160 for marketing authorisation.
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Of the 2025 approvals, several innovative medicines stand out:
➡️ A new treatment for high-risk, non-muscle invasive bladder cancer, a common EU cancer.
➡️ A twice-yearly injectable for HIV PrEP.
➡️ The first oral medicine for postpartum depression.
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EMA's 2025 approvals: Endocrinology led in volume (29 medicines, mostly biosimilars), while #cancer led in innovation (14 of 18 approved cancer medicines contained a new active substance).
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In 2025, we approved 104 human #medicines – the 2nd highest count in 15 years. 38 of these had a new active substance which had never been authorised in the 🇪🇺 before.
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Watch live 🔴
We are now starting our press briefing on medicines that were approved last year and trends we are observing in human medicines 👇
www.linkedin.com/events/emapr...
Don’t miss our posts 🧵 during the press briefing.
Follow #EMAPresser
Two more days until our press briefing. During the event, we will also post live on this platform. To easily find our posts, use the #EMApresser hashtag.
