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RSS FeedPosted by Michael Wonder on 07 Feb 2026
Incyte announces positive CHMP opinion for Zynyz (retifanlimab) for first-line treatment of advanced squamous cell carcinoma of the anal canal
30 January 2026 - The CHMP positive opinion is based on data from the Phase 3 POD1UM-303/InterAACT2 trial which showed patients ...
Posted by Michael Wonder on 04 Feb 2026
EURneffy 1 mg (adrenaline nasal spray) recommended for approval in the EU for emergency treatment of type 1 allergic reactions, including anaphylaxis in children weighing ≥15 kg to <30 kg
2 February 2026 - ARS Pharma’s partner, ALK-Abelló A/S, who owns the rights to market EURneffy in the EU, will distribute ...
Posted by Michael Wonder on 02 Feb 2026
Imfinzi perioperative raegimen recommended for approval in the EU by CHMP for patients with early gastric and gastro-oesophageal cancers
2 February 2026 - Recommendation based on MATTERHORN Phase III trial results which showed a 29% reduction in the risk of ...
Posted by Michael Wonder on 02 Feb 2026
Chiesi Global Rare Diseases and Protalix BioTherapeutics receive positive CHMP opinion for an additional dosing regimen of 2 mg/kg body weight every four weeks for Elfabrio (pegunigalsidase alfa) in the EU
30 January 2026 - Chiesi Global Rare Diseases and Protalix BioTherapeutics today announced an update on pegunigalsidase alfa. ...
Posted by Michael Wonder on 01 Feb 2026
Sanofi’s Rezurock recommended for EU approval by the CHMP to treat chronic graft vs host disease
30 January 2026 - The EMA’s CHMP has adopted a positive opinion recommending the conditional marketing authorisation of Rezurock (belumosudil) in ...
Posted by Michael Wonder on 31 Jan 2026
Kygevvi (doxecitine and doxribtimine) recommended for approval in the European Union as treatment for thymidine kinase 2 deficiency
30 January 2026 - – UCB today announced that the CHMP of the EMA adopted a positive opinion recommending granting ...
Posted by Michael Wonder on 30 Jan 2026
Highlights from the 26-29 January 2026 CHMP meeting
30 January 2026 - The EMA’s CHMP recommended six medicines for approval at its January 2026 meeting. ...
Posted by Michael Wonder on 27 Jan 2026
EMA publishes agenda for 26-29 January 2026 CHMP meeting
26 January 2026 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 14 Dec 2025
Highlights from the 8-11 December 2025 CHMP meeting
12 December 2025 - The EMA’s CHMP recommended seven medicines for approval at its December 2025 meeting. ...
Posted by Michael Wonder on 13 Dec 2025
Aflibercept 8 mg recommended for EU approval for third retinal indication
12 December 2025 - Positive opinion of the CHMP is based on the outcomes from the clinical Phase 3 trial QUASAR ...
Posted by Michael Wonder on 13 Dec 2025
More efficacious dose of Wegovy recommended by the EMA can help people with obesity achieve an average of 20.7% weight loss
12 December 2025 - In the STEP UP programme, people with obesity taking Wegovy 7.2 mg lost an average of ...
Posted by Michael Wonder on 13 Dec 2025
Depemokimab receives positive CHMP opinion for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps
12 December 2025 - Positive opinion based on four Phase 3 trials with statistically significant and clinically meaningful primary endpoints across ...
Posted by Michael Wonder on 13 Dec 2025
Nucala (mepolizumab) receives positive CHMP opinion for treatment of chronic obstructive pulmonary disease
12 December 2025 - Positive opinion based on MATINEE Phase 3 trial showing significant reduction in COPD exacerbations versus placebo in ...
Posted by Michael Wonder on 13 Dec 2025
GSK’s RSV vaccine, Arexvy, receives positive CHMP opinion for all adults 18 years and older
12 December 2025 - GSK today announced that the EMA's CHMP has recommended expanding the indication of its adjuvanted recombinant respiratory ...
Posted by Michael Wonder on 13 Dec 2025
Cytokinetics announces positive CHMP opinion of Myqorzo (aficamten) for the treatment of obstructive hypertrophic cardiomyopathy
12 December 2025 - Cytokinetics today announced that the CHMP of the EMA has adopted a positive opinion recommending marketing authorisation ...