Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2026

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.

Other updates

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.