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RSS FeedPosted by Michael Wonder on 13 May 2026
European Commission approves Pfizer’s Hympavzi for the treatment of adults and adolescents with haemophilia A or B with inhibitors
13 May 2026 - Pfizer today announced that the European Commission has granted marketing authorisation to expand the approved indication ...
Posted by Michael Wonder on 08 May 2026
Bristol Myers Squibb receives European Commission approval of Sotyktu (deucravacitinib) for the treatment of active psoriatic arthritis in adults
8 May 2026 - Bristol Myers Squibb today announced that the European Commission has granted approval to Sotyktu (deucravacitinib), alone ...
Posted 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 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 receives positive CHMP opinion for Itvisma for spinal muscular atrophy
24 April 2026 - Novartis today announced that the CHMP of the EMA has adopted a positive opinion recommending marketing authorisation ...
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 25 Apr 2026
Sanofi’s Cenrifki (tolebrutinib) recommended for EU approval by the CHMP to treat secondary progressive multiple sclerosis without relapses
24 April 2026 - Recommendation based on the HERCULES phase 3 study which demonstrated that brain-penetrant Cenrifki (tolebrutinib) significantly delayed ...
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 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 ...
Posted by Michael Wonder on 10 Apr 2026
Wegovy injection becomes first GLP-1 weight-loss treatment approved for 48-hour controlled-temperature delivery in the EU
9 April 2026 - – The EMA has approved an update to the product information for Wegovy injection that allows ...