European Medicines Agency
@ema.europa.eu
EU regulatory authority working for public and animal health.
We ensure that all medicines available on the EU market are high quality, safe and effective. Based in Amsterdam.
https://www.ema.europa.eu/
We ensure that all medicines available on the EU market are high quality, safe and effective. Based in Amsterdam.
https://www.ema.europa.eu/
EMA also recommends the first immunotherapy treatment for advanced anal cancer: www.ema.europa.eu/en/news/firs...
First immunotherapy-based treatment recommended for advanced anal cancer | European Medicines Agency (EMA)
Zynyz provides an option for adults with squamous cell carcinoma of the anal canal
www.ema.europa.eu
January 30, 2026 at 1:05 PM
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-...
New medicine to treat chronic graft-versus-host disease | European Medicines Agency (EMA)
Rezurock addresses unmet need when other treatments are unsuccessful or unsuitable
www.ema.europa.eu
January 30, 2026 at 1:05 PM
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...
First treatment for rare thymidine kinase 2 deficiency | European Medicines Agency (EMA)
Kygevvi improves motor function of patients with disease onset at or before 12 years of age
www.ema.europa.eu
January 30, 2026 at 1:03 PM
We have recommended for approval the first treatment for a rare genetic disease (Thymidine Kinase 2 Deficiency): www.ema.europa.eu/en/news/firs...
📢 EMA recommends: 6 new medicines 💊 for approval, including the first #GLP1 #medicine indicated for a serious liver disease and an extension of indication to the first emergency nasal spray for allergies in children.
#PublicHealth #medsky
www.ema.europa.eu/en/news/meet...
#PublicHealth #medsky
www.ema.europa.eu/en/news/meet...
January 30, 2026 at 1:02 PM
📢 EMA recommends: 6 new medicines 💊 for approval, including the first #GLP1 #medicine indicated for a serious liver disease and an extension of indication to the first emergency nasal spray for allergies in children.
#PublicHealth #medsky
www.ema.europa.eu/en/news/meet...
#PublicHealth #medsky
www.ema.europa.eu/en/news/meet...
Reposted by European Medicines Agency
Last week in #epidemiology - check out our weekly bulletin - the Communicable Disease Threats Report (CDTR).
Latest issue focuses on:
➡️ #RespiratoryVirus epidemiology in the EU/EEA
➡️ #AvianInfluenza
➡️ #Marburg virus disease
More info: bit.ly/4rbsTct
#IDsky #EpiSky #Prevention #InfectiousDiseases
Latest issue focuses on:
➡️ #RespiratoryVirus epidemiology in the EU/EEA
➡️ #AvianInfluenza
➡️ #Marburg virus disease
More info: bit.ly/4rbsTct
#IDsky #EpiSky #Prevention #InfectiousDiseases
Communicable disease threats report, 17-23 January 2026, week 4
This issue of the ECDC Communicable Disease Threats Report (CDTR) covers the period 17-23 January 2026 and includes updates on respiratory virus epidemiology in the EU/EEA, avian influenza, and Marbur...
www.ecdc.europa.eu
January 26, 2026 at 1:35 PM
Last week in #epidemiology - check out our weekly bulletin - the Communicable Disease Threats Report (CDTR).
Latest issue focuses on:
➡️ #RespiratoryVirus epidemiology in the EU/EEA
➡️ #AvianInfluenza
➡️ #Marburg virus disease
More info: bit.ly/4rbsTct
#IDsky #EpiSky #Prevention #InfectiousDiseases
Latest issue focuses on:
➡️ #RespiratoryVirus epidemiology in the EU/EEA
➡️ #AvianInfluenza
➡️ #Marburg virus disease
More info: bit.ly/4rbsTct
#IDsky #EpiSky #Prevention #InfectiousDiseases
Do you still have questions about the link between #paracetamol use during pregnancy and the risk of neurodevelopmental disorders? Read the latest guest article from Steffen Thirstrup, our Chief Medical Officer, on this topic: www.linkedin.com/company/1523...
#medsky
#publichealth
#medsky
#publichealth
January 26, 2026 at 1:15 PM
Do you still have questions about the link between #paracetamol use during pregnancy and the risk of neurodevelopmental disorders? Read the latest guest article from Steffen Thirstrup, our Chief Medical Officer, on this topic: www.linkedin.com/company/1523...
#medsky
#publichealth
#medsky
#publichealth
New #InsideEMA episode out! 💊
We talk with Monica Dias, EMA’s Head of Supply & Availability of Medicines and Medical Devices, about how the Agency and EU countries work together to prevent and manage medicine shortages.
Awareness + collaboration = better access for patients.
Listen here 👇
#Medsky
We talk with Monica Dias, EMA’s Head of Supply & Availability of Medicines and Medical Devices, about how the Agency and EU countries work together to prevent and manage medicine shortages.
Awareness + collaboration = better access for patients.
Listen here 👇
#Medsky
Inside EMA – Episode 3: Shortages of medicines: A balancing act
YouTube video by European Medicines Agency
www.youtube.com
January 23, 2026 at 3:14 PM
New #InsideEMA episode out! 💊
We talk with Monica Dias, EMA’s Head of Supply & Availability of Medicines and Medical Devices, about how the Agency and EU countries work together to prevent and manage medicine shortages.
Awareness + collaboration = better access for patients.
Listen here 👇
#Medsky
We talk with Monica Dias, EMA’s Head of Supply & Availability of Medicines and Medical Devices, about how the Agency and EU countries work together to prevent and manage medicine shortages.
Awareness + collaboration = better access for patients.
Listen here 👇
#Medsky
Reposted by European Medicines Agency
Today we're hosting the first Interagency #AMR Working Group meeting in Parma.
We're strengthening cooperation across EU agencies to support a #OneHealth approach to tackling antimicrobial resistance.
With @ecdc.europa.eu @ema.europa.eu @echa.europa.eu @eea.europa.eu.
link.europa.eu/JckGBJ
We're strengthening cooperation across EU agencies to support a #OneHealth approach to tackling antimicrobial resistance.
With @ecdc.europa.eu @ema.europa.eu @echa.europa.eu @eea.europa.eu.
link.europa.eu/JckGBJ
January 23, 2026 at 10:18 AM
Today we're hosting the first Interagency #AMR Working Group meeting in Parma.
We're strengthening cooperation across EU agencies to support a #OneHealth approach to tackling antimicrobial resistance.
With @ecdc.europa.eu @ema.europa.eu @echa.europa.eu @eea.europa.eu.
link.europa.eu/JckGBJ
We're strengthening cooperation across EU agencies to support a #OneHealth approach to tackling antimicrobial resistance.
With @ecdc.europa.eu @ema.europa.eu @echa.europa.eu @eea.europa.eu.
link.europa.eu/JckGBJ
The good #pharmacogenomic practice guideline is being updated! A concept paper is open for public consultation until 31 March 2026.
Key proposed changes:
✔️methodology updates
✔️clearer interpretation
✔️consistent reporting
✔️expanded study design guidance.
www.ema.europa.eu/en/good-phar...
Key proposed changes:
✔️methodology updates
✔️clearer interpretation
✔️consistent reporting
✔️expanded study design guidance.
www.ema.europa.eu/en/good-phar...
January 22, 2026 at 1:54 PM
The good #pharmacogenomic practice guideline is being updated! A concept paper is open for public consultation until 31 March 2026.
Key proposed changes:
✔️methodology updates
✔️clearer interpretation
✔️consistent reporting
✔️expanded study design guidance.
www.ema.europa.eu/en/good-phar...
Key proposed changes:
✔️methodology updates
✔️clearer interpretation
✔️consistent reporting
✔️expanded study design guidance.
www.ema.europa.eu/en/good-phar...
Find out more about EMA’s assessment: www.ema.europa.eu/en/news/use-...
Use of paracetamol during pregnancy unchanged in the EU | European Medicines Agency (EMA)
Paracetamol medicines can be used in pregnancy, in accordance with official recommendations
www.ema.europa.eu
January 21, 2026 at 1:59 PM
Find out more about EMA’s assessment: www.ema.europa.eu/en/news/use-...
New systematic review of available evidence published in @lancetobgyn-wh.bsky.social suggests use of paracetamol during pregnancy does not cause autism, aligning with EMA’s previous assessment. Read the study: www.thelancet.com/action/showP...
www.thelancet.com
January 21, 2026 at 1:59 PM
New systematic review of available evidence published in @lancetobgyn-wh.bsky.social suggests use of paracetamol during pregnancy does not cause autism, aligning with EMA’s previous assessment. Read the study: www.thelancet.com/action/showP...
EMA recommended 30 veterinary medicines for marketing authorisation in 2025 - the highest number of recommendations ever in a year for a second consecutive year.
For all the details check out the full report 👇
www.ema.europa.eu/en/news/vete...
For all the details check out the full report 👇
www.ema.europa.eu/en/news/vete...
Veterinary medicines in 2025 | European Medicines Agency (EMA)
30 new medicines recommended for approval; 13 with a new active substance
www.ema.europa.eu
January 19, 2026 at 4:33 PM
EMA recommended 30 veterinary medicines for marketing authorisation in 2025 - the highest number of recommendations ever in a year for a second consecutive year.
For all the details check out the full report 👇
www.ema.europa.eu/en/news/vete...
For all the details check out the full report 👇
www.ema.europa.eu/en/news/vete...
Happy to share this new publication in collaboration with @eortc.org and other stakeholders, setting a new roadmap for the work of the Cancer Medicines Forum.
📢 EORTC & ema.europa.eu, together with key multiple international stakeholders, release a new CMF roadmap setting a clear direction for advancing treatment optimisation across Europe. A meaningful step toward more effective and sustainable cancer care.
Read more here: www.eortc.org/blog/2026/01...
Read more here: www.eortc.org/blog/2026/01...
January 16, 2026 at 2:31 PM
Happy to share this new publication in collaboration with @eortc.org and other stakeholders, setting a new roadmap for the work of the Cancer Medicines Forum.
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
To counter misuse, we launched the #HealthNotHype campaign in 2025 with creators to promote safe, responsible use.
#EMAPresser
January 15, 2026 at 1:26 PM
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
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
#EMAPresser
January 15, 2026 at 1:23 PM
A 2025 milestone: EMA recommended the first-ever treatment to delay the onset of stage 3 type 1 diabetes in adults & children.
#EMAPresser
#EMAPresser
In Europe, cardiovascular diseases remain the leading cause of death (with 1.7 million lives lost every year.), disability and early retirement.
#EMAPresser
#EMAPresser
January 15, 2026 at 1:22 PM
In Europe, cardiovascular diseases remain the leading cause of death (with 1.7 million lives lost every year.), disability and early retirement.
#EMAPresser
#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
✔️58 new active substances
✔️28 orphan medicines
✔️4 advanced therapies,
setting the stage for another impactful year.
#EMAPresser
January 15, 2026 at 1:20 PM
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
✔️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
EMA has 20 years of experience with biosimilars, during which we recommended over 160 for marketing authorisation.
#EMAPresser
January 15, 2026 at 1:18 PM
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
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
➡️ 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
January 15, 2026 at 1:16 PM
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
➡️ 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
#EMAPresser
January 15, 2026 at 1:13 PM
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
#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
#EMAPresser
January 15, 2026 at 1:12 PM
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
#EMAPresser
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
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
January 15, 2026 at 1:00 PM
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
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
The overview of the 2025 EMA’s key recommendations in human #medicines is out! 104 medicines were approved for marketing authorisation, of which 38 have a new active substance that has never been authorised in the EU before. Read more: www.ema.europa.eu/en/news/huma...
#medsky
#medsky
Human medicines in 2025 | European Medicines Agency (EMA)
104 new medicines recommended for approval; 38 had a new active substance
www.ema.europa.eu
January 15, 2026 at 12:52 PM
The overview of the 2025 EMA’s key recommendations in human #medicines is out! 104 medicines were approved for marketing authorisation, of which 38 have a new active substance that has never been authorised in the EU before. Read more: www.ema.europa.eu/en/news/huma...
#medsky
#medsky
EMA and the U.S. Food and Drug Administration have jointly defined 10 principles for good AI practice in the medicines lifecycle. For more details 👉 www.ema.europa.eu/en/news/ema-...
@fda.gov
@fda.gov
EMA and FDA set common principles for AI in medicine development | European Medicines Agency (EMA)
Advancing safe, ethical and aligned AI practices across the medicines lifecycle
www.ema.europa.eu
January 14, 2026 at 3:41 PM
EMA and the U.S. Food and Drug Administration have jointly defined 10 principles for good AI practice in the medicines lifecycle. For more details 👉 www.ema.europa.eu/en/news/ema-...
@fda.gov
@fda.gov
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...
January 14, 2026 at 10:33 AM
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...