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RSS FeedPosted 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 ...
Posted by Michael Wonder on 09 Jan 2026
Annexon submits tanruprubart marketing authorisation application to the EMA for Guillain-Barré syndrome
8 January 2026 - BLA submission with US/European data from FORWARD trial planned in 2026 ...
Posted by Michael Wonder on 07 Jan 2026
Milestone Pharmaceuticals announces acceptance of marketing authorisation application for etripamil nasal spray in PSVT by the EMA
6 January 2026 - Milestone Pharmaceuticals today announced the acceptance of a marketing authorisation application by the EMA seeking the approval ...
Posted by Michael Wonder on 07 Jan 2026
Johnson & Johnson submits application to the EMA for Tecvayli (teclistamab) in combination with Darzalex (daratumumab) subcutaneous formulation for patients with relapsed/refractory multiple myeloma
5 January 2026 - The application is supported by data from the Phase 3 MajesTEC-3 study demonstrating a statistically significant improvement ...
Posted by Michael Wonder on 06 Jan 2026
Moderna announces global regulatory submissions for its investigational seasonal influenza vaccine
5 January 2026 - Moderna today provided an update on regulatory submissions for its investigational seasonal influenza vaccine, mRNA-1010, for adults ...