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RSS FeedPosted by Michael Wonder on 27 Feb 2026
Novartis receives positive CHMP opinion for remibrutinib in chronic spontaneous urticaria
27 February 2026 - Novartis announced today that the CHMP of the EMA has adopted a positive opinion recommending marketing authorisation ...
Posted by Michael Wonder on 23 Feb 2026
Sandoz confirms European Commission approval for Ranluspec (ranibizumab)
23 February 2026 - Launch expected second half of 2026; potential to expand access to life-changing treatment option for European patients. ...
Posted by Michael Wonder on 21 Feb 2026
Aumorlertinib mesylate tablets approved in the EU as monotherapy
20 February 2026 - Hansoh Pharmaceutical is pleased to announce that, on 12 February 2026, aumolertinib mesylate tablets have been ...
Posted by Michael Wonder on 19 Feb 2026
ImmunityBio receives authorisation from the European Commission for Anktiva with BCG for non-muscle invasive bladder cancer carcinoma in situ, expanding global access to 33 countries
18 February 2026 - ImmunityBio today announced that the European Commission has granted conditional marketing authorisation for Anktiva (nogapendekin alfa inbakicept) ...
Posted by Michael Wonder on 18 Feb 2026
Moderna receives European Commission marketing authorisation for COVID-19 vaccine mNEXSPIKE
17 February 2026 - mNEXSPIKE is the third Moderna vaccine authorised in the European Union, strengthening the Company's respiratory vaccine ...
Posted by Michael Wonder on 18 Feb 2026
Cytokinetics announces European Commission approval of Myqorzo (aficamten) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy
17 February 2026 - European Commission Approval Based on Results of SEQUOIA-HCM. ...
Posted by Michael Wonder on 17 Feb 2026
Exdensur (depemokimab) approved by the European Commission for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps
17 February 2026 - Approval based on four Phase 3 trials with statistically significant and clinically meaningful primary data across severe ...
Posted by Michael Wonder on 17 Feb 2026
The European Commission approves more effective dose of injectable Wegovy for adults with obesity; clinical study showed people lost about 21% of their body weight on average
17 February 2026 - The European Commission has approved a new 7.2 mg once weekly maintenance dose of Wegovy (semaglutide injection) ...
Posted by Michael Wonder on 14 Feb 2026
STADA and Bio-Thera receive European marketing authorization for Gotenfia, a biosimilar to Simponi
13 February 2026 - STADA and Bio-Thera Solutions have received a marketing authorisation from the European Commission for their Gotenfia ...
Posted by Michael Wonder on 13 Feb 2026
European Commission approves Amgen's Uplinza for generalised myasthenia gravis
12 February 2026 - Amgen today announced the European Commission has approved Uplinza (inebilizumab) as an add-on treatment to standard therapy ...
Posted by Michael Wonder on 12 Feb 2026
Price, therapeutic value impact international submission times for new drugs
11 February 2026 - The US tends to receive regulatory submissions earlier and more often than other major international regulators, ...
Posted by Michael Wonder on 06 Feb 2026
Nucala (mepolizumab) approved by the European Commission for the treatment of chronic obstructive pulmonary disease
6 February 2026 - GSK today announced the European Commission has approved Nucala (mepolizumab), a monoclonal antibody targeting interleukin-5 , ...
Posted by Michael Wonder on 04 Feb 2026
EURneffy 1 mg (adrenaline nasal spray) recommended for approval in the EU for emergency treatment of type 1 allergic reactions, including anaphylaxis in children weighing ≥15 kg to <30 kg
2 February 2026 - ARS Pharma’s partner, ALK-Abelló A/S, who owns the rights to market EURneffy in the EU, will distribute ...
Posted by Michael Wonder on 02 Feb 2026
Imfinzi perioperative raegimen recommended for approval in the EU by CHMP for patients with early gastric and gastro-oesophageal cancers
2 February 2026 - Recommendation based on MATTERHORN Phase III trial results which showed a 29% reduction in the risk of ...
Posted by Michael Wonder on 02 Feb 2026
Chiesi Global Rare Diseases and Protalix BioTherapeutics receive positive CHMP opinion for an additional dosing regimen of 2 mg/kg body weight every four weeks for Elfabrio (pegunigalsidase alfa) in the EU
30 January 2026 - Chiesi Global Rare Diseases and Protalix BioTherapeutics today announced an update on pegunigalsidase alfa. ...