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RSS FeedPosted 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 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
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 02 Dec 2025
EMA validates type II variation application for Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) for certain patients with muscle-invasive bladder cancer
1 December 2025 - Astellas Pharma today announced that the EMA validated for review a type II variation application for ...
Posted by Michael Wonder on 04 Nov 2025
Chiesi Global Rare Diseases and Protalix BioTherapeutics seek re-examination from the EMA for the negative opinion for Elfabrio (pegunigalsidase alfa) alternative dosing regimen of every four weeks in the EU
3 November 2025 - Every two weeks remains approved as a dosing regimen of Elfabrio in the EU. ...
Posted by Michael Wonder on 15 Oct 2025
Corcept submits marketing authorisation application to EMA for relacorilant as a treatment for patients with platinum-resistant ovarian cancer
14 October 2025 - Corcept Therapeutics has submitted a marketing authorisation application to the EMA for relacorilant to treat patients ...
Posted by Michael Wonder on 09 Oct 2025
Ascendis submits marketing authorisation application to the EMA for TransCon CNP for treatment of children with achondroplasia
8 October 2025 - Ascendis Pharma today announced it has submitted a marketing authorisation application to the EMA for TransCon CNP ...
Posted by Michael Wonder on 07 Oct 2025
European marketing application for AVT23, a proposed biosimilar to Xolair (omalizumab), accepted by the EMA
6 October 2025 - Advanz Pharma today announced that the EMA has accepted a marketing authorisation application for AVT23, a proposed ...
Posted by Michael Wonder on 12 Sep 2025
Johnson & Johnson seeks first EMA approval for icotrokinra aiming to transform the plaque psoriasis treatment paradigm
11 September 2025 - Johnson & Johnson today announced the submission of an application to the EMA seeking the first approval ...
Posted by Michael Wonder on 11 Sep 2025
Enhertu type II variation application validated in the EU for previously treated patients with HER2 positive metastatic solid tumours
11 September 2025 - Submission based on three Phase 2 trials where Daiichi Sankyo and AstraZeneca’s Enhertu showed clinically meaningful ...
Posted by Michael Wonder on 06 Sep 2025
Accrufer assigned priority review in the US by FDA in children with iron deficiency anaemia
4 September 2025 - Pending successful review, approval in the US is anticipated in 2026. ...