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RSS FeedPosted by Michael Wonder on 12 Dec 2023
FDA and EMA accept marstacimab regulatory submissions for the treatment of haemophilia A and B
11 December 2023 - Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend ...
Posted by Michael Wonder on 12 Dec 2023
The European Commission granted marketing authorisation for Vueway (gadopiclenol) in the European Union
11 December 2023 - Vueway is a new, highly stable, macrocyclic gadolinium-based contrast agent (GBCA) for contrast-enhanced magnetic resonance imaging (CE-MRI): ...
Posted by Michael Wonder on 11 Dec 2023
GSK’s Jemperli (dostarlimab) plus chemotherapy approved as the first and only frontline immuno-oncology treatment in the European Union for dMMR/MSI-H primary advanced or recurrent endometrial cancer
11 December 2023 - European Commission also converts previous conditional approval for Jemperli to full approval as a monotherapy for ...
Posted by Michael Wonder on 11 Dec 2023
EMA publishes agenda for 11-14 December 2023 CHMP agenda
11 December 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 10 Dec 2023
Astellas' Veoza (fezolinetant) approved by European Commission for treatment of vasomotor symptoms associated with menopause
10 December 2023 - First in class treatment option reduces number and intensity of hot flashes and night sweats ...
Posted by Michael Wonder on 08 Dec 2023
European Commission approves Pfizer’s Elrexfio for relapsed and refractory multiple myeloma
8 December 2023 - Conditional marketing authorisation is based on clinically meaningful response rates, duration of response, and safety from the ...
Posted by Michael Wonder on 05 Dec 2023
Relaunched EMA website now live
5 December 2023 - EMA has relaunched its website: www.ema.europa.eu. ...
Posted by Michael Wonder on 05 Dec 2023
EU medicines agencies reflect on lessons learned from COVID-19
1 December 2023 - The European Medicines Regulatory Network has been at the forefront of the fight against COVID-19 with ...
Posted by Michael Wonder on 04 Dec 2023
UCB announces European Commission approval of Zilbrysq (zilucoplan) for the treatment of adults with generalised myasthenia gravis
4 December 2023 - Approval supported by pivotal Phase 3 RAISE study in generalised myasthenia gravis which demonstrated treatment with zilucoplan ...
Posted by Michael Wonder on 27 Nov 2023
Formycon announces EMA submission for FYB203, a biosimilar candidate to Eylea (aflibercept)
27 November 2023 - Formycon and its license partner Klinge Biopharma announce that the marketing authorisation application for FYB203, a biosimilar ...
Posted by Michael Wonder on 27 Nov 2023
Krystal Biotech announces EMA validation of marketing authorisation application for Vyjuvek for the treatment of dystrophic epidermolysis bullosa
27 November 2023 - Vyjuvek received orphan drug designation and PRIME designation from the EMA. ...
Posted by Michael Wonder on 27 Nov 2023
EMA accepts Valneva’s Chikungunya vaccine marketing authorisation application for accelerated assessment
27 November 2023 - Valneva today announced that the EMA has performed a technical validation of the marketing authorisation application ...
Posted by Michael Wonder on 27 Nov 2023
AbbVie announces US FDA and EMA updates for epcoritamab (Epkinly/Tepkinly) for the treatment of relapsed/refractory follicular lymphoma
27 November 2023 - Updates are supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial. ...
Posted by Michael Wonder on 25 Nov 2023
Vertex announces EMA validation for marketing authorisation application extension for Kaftrio in combination with ivacaftor to include people with cystic fibrosis and responsive rare mutations
24 November 2023 - Application to add ~200 non-F508del CFTR mutations to the Kaftrio license. ...
Posted by Michael Wonder on 25 Nov 2023
Janssen submits application to the EMA for Rybrevant (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced EGFR mutated non-small cell lung cancer after failure of prior therapy
23 November 2023 - The submission is supported by data from the Phase 3 MARIPOSA-2 study featured in a Late-Breaking ...