Blog
RSS FeedPosted by Michael Wonder on 15 Jan 2025
Acadia Pharmaceuticals submits marketing authorisation application to the EMA for trofinetide for the treatment of Rett syndrome
14 January 2025 - Filing marks company’s first marketing authorisation application in Europe. ...
Posted by Michael Wonder on 07 Jan 2025
EMA commences review of donidalorsen in hereditary angioedema
6 January 2025 - Otsuka announces that the EMA has accepted for review the marketing authorisation application for the hereditary ...
Posted by Michael Wonder on 07 Jan 2025
Norgine submits marketing authorisation application to the EMA for eflornithine (difluoromethylornithine) in high risk neuroblastoma
6 January 2025 - Norgine today announced that it completed its marketing authorisation application filing to the EMA for eflornithine in ...
Posted by Michael Wonder on 24 Dec 2024
Datopotamab deruxtecan application in the EU for patients with advanced non-squamous non-small sell lung cancer voluntarily withdrawn
24 December 2024 - Daiichi Sankyo and AstraZeneca have voluntarily withdrawn the marketing authorisation application in the EU for datopotamab ...
Posted by Michael Wonder on 24 Dec 2024
Blarcamesine receives EMA filing acceptance for treatment of Alzheimer’s disease
23 December 2024 - Submission based on favourable ANAVEX 2-73-AD-004 trial results in patients with early Alzheimer’s disease. ...
Posted by Michael Wonder on 24 Dec 2024
Cytokinetics announces EMA validation of marketing authorisation application for aficamten for the treatment of obstructive hypertrophic cardiomyopathy
23 December 2024 - Cytokinetics today announced that the EMA has validated the marketing authorisation application for aficamten, a next in ...
Posted by Michael Wonder on 23 Dec 2024
Tagrisso approved in the EU for patients with unresectable EGFR mutated lung cancer
23 December 2024 - Approval based on LAURA Phase 3 trial results which showed Tagrisso extended median progression-free survival to ...
Posted by Michael Wonder on 18 Dec 2024
Johnson & Johnson submits application to the EMA seeking approval of a new indication for Imbruvica (ibrutinib) in adult patients with previously untreated mantle cell lymphoma who are eligible for autologous stem cell transplant
18 December 2024 - The European MCL Network Phase 3 TRIANGLE study, evaluated ibrutinib in combination with induction immunochemotherapy, both with ...
Posted by Michael Wonder on 11 Dec 2024
Krystal Biotech provides update on EMA’s on-going regulatory review of B-VEC for dystrophic epidermolysis bullosa
9 December 2024 - CHMP opinion now expected in Q1, 2025. ...
Posted by Michael Wonder on 10 Dec 2024
Chiesi Global Rare Diseases and Protalix BioTherapeutics announce validation of variation submission by EMA for pegunigalsidase alfa
9 December 2024 - Application to label a less frequent dosing regimen at a dose of 2 mg/kg body weight ...
Posted by Michael Wonder on 04 Dec 2024
Anavex Life Sciences announces submission of blarcamesine MAA for treatment of Alzheimer’s disease to EMA
26 November 2024 - First marketing authorisation submission for blarcamesine. ...
Posted by Michael Wonder on 08 Nov 2024
Johnson & Johnson submits applications in the US and EU seeking approval of Darzalex Faspro/Darzalex as subcutaneous monotherapy for high risk smoldering multiple myeloma
8 November 2024 - If approved, Darzalex Faspro will become the first treatment option for patients with smoldering multiple myeloma at ...
Posted by Michael Wonder on 05 Nov 2024
European Medicines Agency confirms acceptance of marketing authorisation application for AVT05, a proposed biosimilar to Simponi (golimumab)
4 November 2024 - Alvotech and Advanz Pharma today announced that the EMA has accepted a marketing authorisation application for AVT05, ...
Posted by Michael Wonder on 28 Oct 2024
Astellas provides update on marketing authorisation application for avacincaptad pegol in the European Union
28 October 2024 - Astellas today announced the company's decision to withdraw its marketing authorisation application from the EMA for ...
Posted by Michael Wonder on 17 Oct 2024
Alnylam submits regulatory application to the EMA for vutrisiran for the treatment of ATTR amyloidosis with cardiomyopathy
16 October 2024 - Type II variation submission based on the positive HELIOS-B Phase 3 trial in which vutrisiran significantly reduced ...