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RSS FeedPosted 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. ...
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 31 Jan 2026
Kygevvi (doxecitine and doxribtimine) recommended for approval in the European Union as treatment for thymidine kinase 2 deficiency
30 January 2026 - – UCB today announced that the CHMP of the EMA adopted a positive opinion recommending granting ...
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 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 ...
Posted by Michael Wonder on 22 Jan 2026
IntraBio receives European Commission approval of Aqneursa for the treatment of Niemann-Pick type C disease
21 January 2026 - IntraBio today announced that the European Commission granted marketing authorisation to Aqneursa (levacetylleucine) for the treatment ...
Posted by Michael Wonder on 21 Jan 2026
Dawnzera (donidalorsen) granted European Union marketing authorisation for the prevention of hereditary angioedema
21 January 2026 - Otsuka announces that the European Commission has granted marketing authorization for Dawnzera (donidalorsen) for the routine ...
Posted by Michael Wonder on 19 Jan 2026
Sobi receives European Commission approval for Aspaveli (pegcetacoplan) for the treatment of C3G and primary IC-MPGN
16 January 2026 - Sobi today announced that the European Commission has approved Aspaveli (pegcetacoplan) for the treatment of adult ...
Posted by Michael Wonder on 19 Jan 2026
Eylea 8 mg approved in the EU for third retinal indication
16 January 2026 - The European Commission has granted marketing authorisation in the EU for Eylea™ 8 mg (aflibercept 8 mg, ...