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RSS FeedPosted by Michael Wonder on 27 Mar 2026
Eisai and Nuvation Bio announce marketing authorisation application for taletrectinib for the treatment of advanced ROS1 positive non-small cell lung cancer validated by the EMA
26 March 2026 - Additional filings are planned for the UK, Canada and other regions included in Eisai's licensed territories. ...
Posted by Michael Wonder on 25 Mar 2026
Anavex Life Sciences provides update on regulatory review in the EU for blarcamesine to treat early Alzheimer’s disease
25 March 2026 - Anavex Life Sciences today announced that it has withdrawn its application for the marketing authorisation of ...
Posted by Michael Wonder on 11 Mar 2026
Tecvayli (teclistamab) monotherapy application submitted to the EMA for relapsed/refractory multiple myeloma after at least one prior therapy
10 March 2026 - Johnson & Johnson today announced the submission of a type II variation application to the EMA seeking ...
Posted by Michael Wonder on 11 Mar 2026
Lenz Therapeutics announces submission of marketing authorisation application to the EMA for Vizz for the treatment of presbyopia
10 March 2026 - Lenz Therapeutics today announced that it has submitted a marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 10 Mar 2026
Chiesi Global Rare Diseases and Protalix BioTherapeutics announce European Commission approval of additional dosing regimen of every four weeks for Elfabrio (pegunigalsidase alfa)
9 March 2026 - Chiesi Global Rare Diseases and Protalix BioTherapeutics today announced that the European Commission has approved the 2 ...
Posted by Michael Wonder on 28 Feb 2026
Asieris announces EMA accepts marketing authorisation application for APL-1702
27 February 2026 - Asieris Pharmaceuticals announced today that its marketing authorisation application for APL-1702 (Cevira) for the treatment of high ...
Posted by Michael Wonder on 28 Feb 2026
Photocure partner Asieris announces that EMA has accepted marketing authorisation application for Cevira in Europe
27 February 2026 - Photocure announces that its partner Asieris Pharmaceuticals communicated today that its marketing authorisation application for Cevira (APL-1702) ...
Posted by Michael Wonder on 19 Feb 2026
Enhertu type II variation application validated in the EU as post-neoadjuvant treatment for patients with HER2 positive early breast cancer
19 February 2026 - Based on DESTINY-Breast05 Phase 3 trial results, which showed Enhertu reduced the risk of invasive disease ...
Posted by Michael Wonder on 18 Feb 2026
Telix submits European marketing authorisation application for TLX101-Px for brain cancer imaging
18 February 2026 - Telix today announces that it has submitted a marketing authorisation application in Europe for TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine, ...
Posted by Michael Wonder on 04 Feb 2026
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) in adults and adolescents with vitiligo
3 February 2026 - Submissions are supported by data from the Phase 3 Viti-Up clinical studies demonstrating upadacitinib achieved the co-primary ...
Posted by Michael Wonder on 03 Feb 2026
Acadia Pharmaceuticals provides update on regulatory submission for trofinetide for the treatment of Rett syndrome in the European Union
2 February 2026 - Acadia Pharmaceuticals today announced that the Company was informed by the CHMP of the EMA of a ...
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 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 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 ...