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RSS FeedPosted 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
EMA publishes agenda for 26-29 January 2026 CHMP meeting
26 January 2026 - The EMA has published a draft agenda for this week's CHMP meeting. ...
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 ...
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, ...
Posted by Michael Wonder on 19 Jan 2026
Enhertu plus pertuzumab type II variation application validated in the EU as first-line treatment of patients with HER2 positive metastatic breast vancer
19 January 2026 - Based on DESTINY-Breast09 Phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s Enhertu in combination ...
Posted by Michael Wonder on 17 Jan 2026
Fondazione Telethon receives european marketing authorisation for Waskyra (etuvetidigene autotemcel), a gene therapy for the treatment of Wiskott-Aldrich syndrome
16 January 2026 - The European Commission’s decision follows the positive opinion issued by the EMA’s CHMP in November 2025. ...
Posted by Michael Wonder on 17 Jan 2026
Human medicines in 2025
15 January 2026 - In 2025, the EMA recommended 104 medicines for marketing authorisation. ...
Posted by Michael Wonder on 14 Jan 2026
Sandoz confirms European Commission approval of Ondibta (insulin glargine), strengthening overall biosimilars leadership and position in diabetes
14 January 2026 - Expected launch by early 2027; potential to expand access to insulin treatment option for tens of millions ...
Posted by Michael Wonder on 12 Jan 2026
Sanofi’s Teizeild approved in the EU for patients with stage 2 type 1 diabetes
12 January 2026 - Approval based on the TN-10 Phase 2 study that demonstrated a significant delay of onset of ...
Posted by Michael Wonder on 09 Jan 2026
GSK’s Shingrix (recombinant zoster vaccine) pre-filled syringe presentation approved by the European Commission
7 January 2026 - New presentation will begin rolling out across EU countries in 2026. ...
Posted by Michael Wonder on 09 Jan 2026
Wockhardt files marketing authorisation application for WCK 5222 with EMA
7 January 2026 - Wockhardt has successfully filed a marketing authorisation application with the EMA for its novel antibiotic, WCK ...