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RSS FeedPosted 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 07 Feb 2026
Incyte announces positive CHMP opinion for Zynyz (retifanlimab) for first-line treatment of advanced squamous cell carcinoma of the anal canal
30 January 2026 - The CHMP positive opinion is based on data from the Phase 3 POD1UM-303/InterAACT2 trial which showed patients ...
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 04 Feb 2026
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) in adults and adolescents with vitiligo
3 February 2026 - Submissions are supported by data from the Phase 3 Viti-Up clinical studies demonstrating upadacitinib achieved the co-primary ...
Posted by Michael Wonder on 03 Feb 2026
Acadia Pharmaceuticals provides update on regulatory submission for trofinetide for the treatment of Rett syndrome in the European Union
2 February 2026 - Acadia Pharmaceuticals today announced that the Company was informed by the CHMP of the EMA of a ...
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 01 Feb 2026
Sanofi’s Rezurock recommended for EU approval by the CHMP to treat chronic graft vs host disease
30 January 2026 - The EMA’s CHMP has adopted a positive opinion recommending the conditional marketing authorisation of Rezurock (belumosudil) in ...
Posted by Michael Wonder on 30 Jan 2026
Highlights from the 26-29 January 2026 CHMP meeting
30 January 2026 - The EMA’s CHMP recommended six medicines for approval at its January 2026 meeting. ...
Posted by Michael Wonder on 28 Jan 2026
The European Commission extended the marketing authorisation for Vueway (gadopiclenol) in the European Union for use in paediatric patients under 2 years of age
27 January 2026 - Bracco Imaging announces that on 23 January 2026, the European Commission amended the Marketing Authorisation for Vueway ...
Posted by Michael Wonder on 27 Jan 2026
Eisai submits marketing authorisation variation to EMA for intravenous maintenance dosing every four weeks with Leqembi (lecanemab)
26 January 2026 - BioArctic AB's partner Eisai announced today that they have submitted a proposed marketing authorisation variation to the ...
Posted by Michael Wonder on 26 Jan 2026
GSK’s RSV vaccine, Arexvy, receives European approval for expanded use in all adults 18 years and older
26 January 2026 - GSK today announced that its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, has been approved by ...