Source: European Union 2 Published on: 2026-05-22
Eight new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its May 2026 meeting.
Jascayd (nerandomilast) received a positive opinion from the CHMP for the treatment of idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF), two serious lung diseases that involve progressive and irreversible scarring (fibrosis) of the lung tissue. There are limited treatment options for people suffering from IPF or PPF. Both conditions can cause severe symptoms, including difficulty breathing, leading to hospitalisation and ultimately death within a few years of diagnosis due to a progressive decline in lung function. See more details in the news announcement in the grid below.
The CHMP recommended granting a conditional marketing authorisation for Vijoice (alpelisib), for the treatment of patients with severe PIK3CA-related overgrowth spectrum (PROS) disorders. PROS is a diverse group of rare genetic conditions that are characterised by uncontrolled growth of some tissues in the body, causing malformations and tumours affecting the skin, bones, blood vessels and brain. There is currently no authorised medicine for PROS and treatment consists of supportive care, including surgery and procedures to block overgrown blood vessels. See more details in the news announcement in the grid below.
The committee recommended granting a marketing authorisation for Boey (trenibotulinumtoxinE), for the temporary improvement in the appearance of moderate to severe lines between the eyebrows when these have an important psychological impact in adults.
The CHMP adopted a positive opinion for Etcamah (camizestrant), for the treatment of adults with locally advanced or metastatic breast cancer with a specific mutation in the ESR1 gene.
The CHMP recommended granting a marketing authorisation for three hybrid applications, which rely in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data:
• Ablymico (liraglutide), indicated for weight management.
• Liraglutide STADA (liraglutide), for the treatment of insufficiently controlled type 2 diabetes as an adjunct to diet and exercise.
• Colchicine AGEPHA Pharma (colchicine), for the secondary prevention of atherothrombotic events in adults with coronary disease who have been stable for at least six months.
A biosimilar medicine, Vislyfa (ranibizumab), received a positive opinion for the treatment of several eye diseases causing vision impairment.
Negative opinion for one medicine
The committee recommended not granting a marketing authorisation for Deqtynet (copper (64Cu) oxodotreotide), a diagnostic medicine intended for use with positron emission tomography (PET) imaging to detect well-differentiated neuroendocrine tumours (NETs) in adults. Neuroendocrine tumours are rare tumours that can develop in different parts of the body, such as the pancreas, intestines or lungs. Well-differentiated means that the cells look and behave like normal cells and grow slowly.
For more information on this negative opinion, see the question-and-answer document in the grid below.
Recommendations on extensions of therapeutic indication for 13 medicines
The committee recommended extensions of indication for 14 medicines that are already authorised in the European Union (EU):
Braftovi, Enhertu, Erbitux, Fasenra, Hetronifly, Iclusig, Keytruda, Maviret, Padcev, Palynziq, Sogroya, Tepkinly and Trodelvy.
Withdrawal of applications
Applications for initial marketing authorisation for two medicines were withdrawn:
• Orblid (bevacizumab), for the treatment of hereditary haemorrhagic telangiectasia, a genetic disease that causes abnormalities in the capillaries (small blood vessels that connect arteries with veins).
• Veblocema (infliximab), for the treatment of rheumatoid arthritis, Crohn’s disease and ulcerative colitis.
Question-and-answer documents on the withdrawal of these two applications are available in the grid below.
The CHMP has recommended an extension to the marketing authorisation for Wegovy (semaglutide) for weight management to add a daily oral tablet as alternative formulation to weekly subcutaneous injections. Wegovy tablets can be used, together with diet and physical activity, in adults with obesity, or in those who are overweight and have at least one weight-related comorbidity. This is the first glucagon-like peptide (GLP-1) receptor agonist for weight management developed for oral use.
See more details in the news announcement in the grid below.
Key figures from the May 2026 CHMP meeting are represented in the graphic below.
CHMP statistics: Text version
May 2026 statistics – monthly and cumulative figures for CHMP opinions and withdrawn applications:
• 8 positive opinions on new medicines: 3 new non-orphan medicine, 1 orphan medicines, 1 biosimilar and 3 generic, hybrid or informed consent medicine. Total in 2026: 36
8 positive opinions on new medicines: 3 new non-orphan medicine, 1 orphan medicines, 1 biosimilar and 3 generic, hybrid or informed consent medicine. Total in 2026: 36
• 1 negative opinions on new medicines. Total in 2026: 3
1 negative opinions on new medicines. Total in 2026: 3
• 18 positive opinions on extensions of therapeutic indication. Total in 2026: 59
18 positive opinions on extensions of therapeutic indication. Total in 2026: 59
• 2 withdrawn applications for new medicines. Total in 2026: 5
2 withdrawn applications for new medicines. Total in 2026: 5
Positive recommendations on new medicines
trenibotulinumtoxinE
AbbVie Deutschland GmbH & Co
Temporary improvement in the appearance of moderate to severe lines between the eyebrows when these have an important psychological impact in adult patients
Boey : pending EC decision
Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) is indicated for the treatment of adult patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1‑mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor (for biomarker based patient-selection, see section 4.2 and 5.1)
Etcamah : pending EC decision
Boehringer Ingelheim International GmbH
Treatment of adult patients with Idiopathic Pulmonary Fibrosis (IPF) and adult patients with Progressive Pulmonary Fibrosis (PPF)
Jascayd : pending EC decision
New medicine for two types of pulmonary fibrosis
Novartis Europharm Limited
Vijoice is indicated for the treatment of adult and paediatric patients aged 2 years and older with severe or life-threatening manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy
This medicine was designated an orphan medicine
Vijoice : pending EC decision
First medicine to treat rare uncontrolled growth of body tissues
Positive recommendations on new hybrid medicines
STADA Arzneimittel AG
Treatment of diabetes and weight management
Ablymico : pending EC decision
STADA Arzneimittel AG
Treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes as an adjunct to diet and exercise
Liraglutide STADA : pending EC decision
Colchicine AGEPHA Pharma
Agepha Pharma s.r.o.
Indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in patients with atherosclerotic disease or with multiple risk factors for cardiovascular disease
Colchicine AGEPHA Pharma : pending EC decision
Positive recommendations on new biosimilar medicine
The treatment of neovascular (wet) age-related macular degeneration (AMD); The treatment of visual impairment due to diabetic macular oedema (DME) – The treatment of proliferative diabetic retinopathy (PDR); The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO); The treatment of visual impairment due to choroidal neovascularisation (CNV)
Vislyfa: pending EC decision
Negative recommendations on new medicines
copper (64Cu) oxodotreotide
Cis Bio International
For positron emission tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated neuroendocrine tumours (NETs) excluding neuroblastomas
This medicine was designated an orphan medicine.
Deqtynet : pending EC decision
Positive recommendations on extensions of therapeutic indications
Pierre Fabre Medicament
Braftovi : pending EC decision
trastuzumab deruxtecan
Daiichi Sankyo Europe GmbH
Enhertu: pending EC decision (EMA/VR/0000293327)
• Erbitux: pending EC decision (EMA/VR/0000326978)
• Erbitux: pending EC decision (EMA/VR/0000327014)
Fasenra: pending EC decision
Accord Healthcare S.L.U.
Hetronifly: pending EC decision
Incyte Biosciences Distribution B.V.
Iclusig: pending EC decision
Merck Sharp & Dohme B.V.
• Keytruda: pending EC decision (EMA/VR/0000312515)
• Keytruda: pending EC decision (EMA/VR/0000316576)
glecaprevir / pibrentasvir
AbbVie Deutschland GmbH & Co. KG
Maivret : pending EC decision
Astellas Pharma Europe B.V.
Padcev : pending EC decision
BioMarin International Limited
Palynziq : pending EC decision
Sogroya : pending EC decision
AbbVie Deutschland GmbH & Co. KG
Tepkinly : pending EC decision
sacituzumab govitecan
Gilead Sciences Ireland Unlimited Company
Trodelvy : pending EC decision
Withdrawal of initial marketing authorisation applications
Celltrion Healthcare Hungary Kft.
Veblocema : questions and answers
Laboratoires Delbert
Orblid : questions and answers
Wegovy : pending EC decision (EMA/X/0000296344)
First oral GLP-1 treatment for weight management
Please note that not all documents associated with this page are published at the same time. This page is updated with new documents as soon as they become available. Therefore, users are asked to check the page regularly.
• Committee for Medicinal Products for Human Use (CHMP): 18-21 May 2026
• Committee for Medicinal Products for Human Use (CHMP)
• New medicine for two types of pulmonary fibrosis
• First oral GLP-1 treatment for weight management
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