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RSS FeedPosted by Michael Wonder on 30 Apr 2026
European Commission approves Henlius and Organon's Poherdy (pertuzumab), the first approved biosimilar to Perjeta (pertuzumab) in Europe
29 April 2026 - Shanghai Henlius Biotech, and Organon today announced the European Commission has granted marketing authorization for Poherdy (pertuzumab) ...
Posted by Michael Wonder on 30 Apr 2026
Richter receives European Commission approval for Tuyory, its biosimilar tocilizumab in multiple indications
29 April 2026 - Gedeon Richter announces today that the European Commission granted marketing authorisation for Tuyory, its biosimilar to ...
Posted by Michael Wonder on 30 Apr 2026
Norgine announces European Commission marketing authorisation for Xolremdi (mavorixafor), the first authorised treatment for patients with WHIM syndrome in the European Union
29 April 2026 - Norgine today announced that the European Commission has granted marketing authorisation for mavorixafor as Xolremdi following a ...
Posted by Michael Wonder on 28 Apr 2026
GSK’s investigational liver therapy, efimosfermin, receives US FDA breakthrough therapy and EMA Priority Medicines (PRIME) designations for MASH
27 April 2026 - GSK today announced that efimosfermin, a once monthly investigational liver therapy, has been granted breakthrough therapy designation ...
Posted by Michael Wonder on 27 Apr 2026
Novartis Rhapsido receives European Commission approval as first oral targeted treatment for chronic spontaneous urticaria
27 April 2026 - Novartis announced today that the European Commission approved Rhapsido (remibrutinib) for chronic spontaneous urticaria in adult patients ...
Posted by Michael Wonder on 25 Apr 2026
Highlights from 20-23 April 2026 CHMP meeting
24 April 2026 - The EMA’s CHMP recommended five medicines for approval at its April 2026 meeting. ...
Posted by Michael Wonder on 25 Apr 2026
Novartis withdraws EMA application for adding new indication for Pluvicto
24 April 2026 - Novartis has withdrawn a EMA type II variation application for Pluvicto to treat adult patients with prostate-specific ...
Posted by Michael Wonder on 25 Apr 2026
Arrowhead Pharmaceuticals receives positive CHMP opinion recommending approval of Redemplo (plozasiran) to reduce triglycerides in adults with familial chylomicronaemia syndrome in Europe
24 April 2026 - The CHMP opinion is based on positive results from the Phase 3 PALISADE study where Redemplo ...
Posted by Michael Wonder on 24 Apr 2026
EMA sees slight improvement in approval submission predictability, reversing trend
23 April 2026 - The trend for the timing of initial marketing authorisation applications to be less predictable is slowly reversing ...
Posted by Michael Wonder on 23 Apr 2026
EMA publishes agenda for 20-23 April 2026 CHMP meeting
20 April 2026 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 23 Apr 2026
Ojemda approved in the European Union as the first targeted therapy in relapsed or refractory pediatric low-grade glioma regardless of BRAF alteration
22 April 2026 - Approval is based on pivotal Phase 2 FIREFLY-1 data demonstrating meaningful and durable tumour responses. ...
Posted by Michael Wonder on 22 Apr 2026
Moderna receives European Commission marketing authorisation for mCOMBRIAX, Moderna's mRNA combination vaccine against influenza and COVID-19
21 April 2026 - mCOMBRIAX will be made available in the European Union, subject to national regulatory and access procedures ...
Posted by Michael Wonder on 21 Apr 2026
European Commission approves Merck’s Enflonsia (clesrovimab) for the prevention of respiratory syncytial virus lower respiratory tract disease in infants during their first RSV season
17 April 2026 - Merck announced today that the European Commission has approved Enflonsia (clesrovimab) for the prevention of respiratory syncytial ...
Posted by Michael Wonder on 21 Apr 2026
EMA validates type II variation application for Padcev (enfortumab vedotin) plus Keytruda (pembrolizumab) in cisplatin-eligible patients with muscle invasive bladder cancer
23 March 2026 - Astellas today announced that the European Medicines Agency (EMA) has validated for review a Type II ...
Posted by Michael Wonder on 13 Apr 2026
Dupixent (dupilumab) approved in the EU as the first targeted medicine to treat young children with chronic spontaneous urticaria
13 April 2026 - Regeneron Pharmaceuticals and Sanofi today announced that the European Commission has approved Dupixent (dupilumab) for the treatment ...