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RSS FeedPosted 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 ...
Posted by Michael Wonder on 24 Dec 2025
Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia
23 December 2025 - Approval based on the LUNA 3 Phase 3 study that demonstrated rapid and durable platelet response and ...
Posted by Michael Wonder on 20 Dec 2025
European Commission approves Tremfya (guselkumab) for the treatment of children with plaque psoriasis, marking the first paediatric indication for an IL-23 inhibitor
19 December 2025 - The decision is supported by the Phase 3 PROTOSTAR study, where guselkumab demonstrated higher levels of skin ...
Posted by Michael Wonder on 18 Dec 2025
Datroway type II variation application validated in the EU as first-line treatment for patients with metastatic triple negative breast cancer who are not candidates for immunotherapy
18 December 2025 - Based on TROPION-Breast02 Phase 3 trial results where Daiichi Sankyo and AstraZeneca’s Datroway is the first ...
Posted by Michael Wonder on 16 Dec 2025
Saphnelo approved in the EU for subcutaneous self-administration as a new pre-filled pen for systemic lupus erythematosus
16 December 2025 - AstraZeneca’s Saphnelo (anifrolumab) has been approved in the European Union for subcutaneous self-administration as a pre-filled ...
Posted by Michael Wonder on 16 Dec 2025
Leo Pharma submits adolescent label expansion application for Anzupgo to EMA
15 December 2025 - Leo Pharma today announced submission of a label expansion application to the EMA to expand the ...
Posted by Michael Wonder on 14 Dec 2025
Highlights from the 8-11 December 2025 CHMP meeting
12 December 2025 - The EMA’s CHMP recommended seven medicines for approval at its December 2025 meeting. ...
Posted by Michael Wonder on 13 Dec 2025
Aflibercept 8 mg recommended for EU approval for third retinal indication
12 December 2025 - Positive opinion of the CHMP is based on the outcomes from the clinical Phase 3 trial QUASAR ...
Posted by Michael Wonder on 13 Dec 2025
More efficacious dose of Wegovy recommended by the EMA can help people with obesity achieve an average of 20.7% weight loss
12 December 2025 - In the STEP UP programme, people with obesity taking Wegovy 7.2 mg lost an average of ...
Posted by Michael Wonder on 13 Dec 2025
Depemokimab receives positive CHMP opinion for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps
12 December 2025 - Positive opinion based on four Phase 3 trials with statistically significant and clinically meaningful primary endpoints across ...