Blog
RSS FeedPosted by Michael Wonder on 24 Dec 2025
Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia
23 December 2025 - Approval based on the LUNA 3 Phase 3 study that demonstrated rapid and durable platelet response and ...
Posted by Michael Wonder on 20 Dec 2025
European Commission approves Tremfya (guselkumab) for the treatment of children with plaque psoriasis, marking the first paediatric indication for an IL-23 inhibitor
19 December 2025 - The decision is supported by the Phase 3 PROTOSTAR study, where guselkumab demonstrated higher levels of skin ...
Posted by Michael Wonder on 18 Dec 2025
Datroway type II variation application validated in the EU as first-line treatment for patients with metastatic triple negative breast cancer who are not candidates for immunotherapy
18 December 2025 - Based on TROPION-Breast02 Phase 3 trial results where Daiichi Sankyo and AstraZeneca’s Datroway is the first ...
Posted by Michael Wonder on 16 Dec 2025
Saphnelo approved in the EU for subcutaneous self-administration as a new pre-filled pen for systemic lupus erythematosus
16 December 2025 - AstraZeneca’s Saphnelo (anifrolumab) has been approved in the European Union for subcutaneous self-administration as a pre-filled ...
Posted by Michael Wonder on 16 Dec 2025
Leo Pharma submits adolescent label expansion application for Anzupgo to EMA
15 December 2025 - Leo Pharma today announced submission of a label expansion application to the EMA to expand the ...
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 ...
Posted by Michael Wonder on 08 Dec 2025
EMA publishes agenda for 8-11 December 2025 CHMP meeting
8 December 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 04 Dec 2025
Pre-filled syringe presentation of Byooviz, Samsung Bioepis’ biosimilar to Lucentis (ranibizumab), gains European approval
2 December 2025 - Samsung Bioepis today announced that the EMA’s CHMP has adopted a positive opinion for Byooviz pre-filled syringe, ...
Posted by Michael Wonder on 02 Dec 2025
Samsung Bioepis announces launch of denosumab biosimilars, Obodence and Xbryk in Europe
1 December 2025 - Samsung Bioepis today announced the launch of Obodence (60 mg pre-filled syringe) and Xbryk (120 mg vial), ...