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RSS FeedPosted 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), ...
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 27 Nov 2025
Alvotech announces approval of AVT03, a biosimilar to Prolia and Xgeva (denosumab) in the European Economic Area
November 24, 2025 - Alvotech today announced that the European Commission has approved AVT03 as a biosimilar to Prolia and ...
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 24 Nov 2025
Bristol Myers Squibb receives approval from the European Commission to expand use of CAR T cell therapy Breyanzi for relapsed or refractory mantle cell lymphoma
24 November 2025 - In the TRANSCEND MCL trial, 82.7% of patients responded to Breyanzi, with 71.6% of patients achieving complete ...
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 ...