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RSS FeedPosted 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
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), ...
Posted by Michael Wonder on 02 Dec 2025
EMA validates type II variation application for Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) for certain patients with muscle-invasive bladder cancer
1 December 2025 - Astellas Pharma today announced that the EMA validated for review a type II variation application for ...
Posted by Michael Wonder on 25 Nov 2025
Dupixent (dupilumab) approved as the first targeted medicine in the European Union in over a decade for chronic spontaneous urticaria
25 November 2025 - Approval based on Phase 3 trials showing Dupixent significantly reduced itch and hives at 24 weeks compared ...
Posted by Michael Wonder on 19 Nov 2025
Lynkuet (elinzanetant) approved in the EU for the treatment of moderate to severe vasomotor symptoms associated with menopause or endocrine therapy for breast cancer
19 November 2025 - The European Commission has granted marketing authorisation in the European Union for elinzanetant, under the brand name ...
Posted by Michael Wonder on 19 Nov 2025
Libtayo (cemiplimab) approved in the European Union as first and only immunotherapy for adjuvant treatment of cutaneous squamous cell carcinoma with high risk of recurrence after surgery and radiation
19 November 2025 - Approval based on results of landmark Phase 3 C-POST trial that show Libtayo is first immunotherapy to ...
Posted by Michael Wonder on 19 Nov 2025
European Commission approves Roche’s Lunsumio subcutaneous for relapsed or refractory follicular lymphoma
19 November 2025 - Roche announced today that the European Commission has granted conditional marketing authorisation of Lunsumio (mosunetuzumab) subcutaneous for ...
Posted by Michael Wonder on 19 Nov 2025
European Commission approves Brinsupri (brensocatib) as the first and only treatment approved for non-cystic fibrosis bronchiectasis in the European Union
18 November 2025 - Brinsupri was reviewed under EMA's accelerated assessment pathway as it is considered of major interest for public ...
Posted by Michael Wonder on 15 Nov 2025
Highlights from the 10-13 November 2025 CHMP meeting
14 November 2025 - The EMA’s CHMP recommended ten medicines for approval at its November 2025 meeting. ...
Posted by Michael Wonder on 15 Nov 2025
Sanofi’s Teizeild recommended for EU approval by the CHMP for patients with stage 2 type 1 diabetes
14 November 2025 - The EMA’s CHMP has adopted a positive opinion recommending the approval of Teizeild (teplizumab) to delay ...
Posted by Michael Wonder on 11 Nov 2025
EMA publishes agenda for 10-13 November 2025 CHMP meeting
10 November 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 04 Nov 2025
Chiesi Global Rare Diseases and Protalix BioTherapeutics seek re-examination from the EMA for the negative opinion for Elfabrio (pegunigalsidase alfa) alternative dosing regimen of every four weeks in the EU
3 November 2025 - Every two weeks remains approved as a dosing regimen of Elfabrio in the EU. ...