EMA also recommends the first immunotherapy treatment for advanced anal cancer: www.ema.europa.eu/en/news/firs...

Positive opinion for one medicine to treat a condition in which donor cells attack the body’s organs after a transplant (Chronic Graft Versus-host Disease) www.ema.europa.eu/en/news/new-...

We have recommended for approval the first treatment for a rare genetic disease (Thymidine Kinase 2 Deficiency): www.ema.europa.eu/en/news/firs...

Find out more about EMA’s assessment: www.ema.europa.eu/en/news/use-...

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.

#EMAPresser

A 2025 milestone: EMA recommended the first-ever treatment to delay the onset of stage 3 type 1 diabetes in adults & children.

#EMAPresser

In Europe, cardiovascular diseases remain the leading cause of death (with 1.7 million lives lost every year.), disability and early retirement.

#EMAPresser

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.

#EMAPresser

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.

#EMAPresser

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.

#EMAPresser

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).

#EMAPresser

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.

#EMAPresser

One more day until our press briefing. During the Linkedin live stream, we will address relevant questions coming into the comment section. Have a look at the event page! www.linkedin.com/events/74149...