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RSS FeedPosted by Michael Wonder on 28 Oct 2023
ImmunoGen announces European Medicines Agency acceptance of marketing authorisation application for mirvetuximab soravtansine in platinum-resistant ovarian cancer
27 October 2023 - ImmunoGen today announced that the EMA has accepted the marketing authorisation application for mirvetuximab soravtansine (Elahere) ...
Posted by Michael Wonder on 26 Oct 2023
Valneva submits Chikungunya vaccine marketing application to EMA and announces CHMP accelerated assessment
25 October 2023 - Valneva today announces the submission of a marketing application with the EMA for approval of the ...
Posted by Michael Wonder on 25 Oct 2023
Orphelia Pharma files EU marketing authorisation application for Kizfizo
24 October 2023 - Orphelia Pharma today announces the filing of a centralised marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 24 Oct 2023
Ipsen updates on EU marketing authorisation application for odevixibat in Alagille syndrome
23 October 2023 - Ipsen plans to submit a new marketing authorisation application for the treatment of Alagille syndrome by the ...
Posted by Michael Wonder on 11 Oct 2023
Cosmo announces submission of Winlevi to the EMA
10 October 2023 - Submission to EMA is supported and based on the efficacy and safety evidence gathered in two identical, ...
Posted by Michael Wonder on 07 Oct 2023
Janssen submits application to the European Medicines Agency for Rybrevant (amivantamab) in combination with chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations
6 October 2023 - Type II extension of indication application is supported by data from PAPILLON, the first randomised Phase 3 ...
Posted by Michael Wonder on 03 Oct 2023
Formycon and Fresenius Kabi announce EMA acceptance of the marketing authorisation application for FYB202, an ustekinumab biosimilar candidate
29 September 2023 - Formycon and its commercialisation partner Fresenius Kabi today announced that the EMA has accepted the marketing authorisation ...
Posted by Michael Wonder on 30 Sep 2023
Geron announces EMA validation of marketing authorisation application for imetelstat for the treatment of lower risk MDS
29 September 2023 - Geron Corporation today announced that the EMA has validated the marketing authorisation application for imetelstat, a first-in-class ...
Posted by Michael Wonder on 29 Sep 2023
STADA and Calliditas announce the filing for full marketing authorisation of Kinpeygo in the EU
28 September 2023 - Submission to the CHMP for full approval is based on the full two-year data set from the ...
Posted by Michael Wonder on 18 Sep 2023
BioMarin receives positive CHMP opinion in Europe to expand use of Voxzogo (vosoritide) to treat children aged 4 months and older with achondroplasia
15 September 2023 - BioMarin today announced that the EMA's CHMP has adopted a positive opinion recommending marketing authorisation to expand ...
Posted by Michael Wonder on 13 Sep 2023
European Medicines Agency validates type II variation for Astellas' Xtandi (enzalutamide) for treatment of non-metastatic hormone sensitive prostate cancer with high risk biochemical recurrence
13 September 2023 - Application based on results from Phase 3 EMBARK trial, which showed Xtandi plus leuprolide reduced risk ...
Posted by Michael Wonder on 09 Sep 2023
Janssen submits marketing authorisation application to the EMA seeking approval of erdafitinib for the treatment of patients with locally advanced or metastatic urothelial cancer with susceptible FGFR alterations
8 September 2023 - The submission is based on results from the Phase 3 THOR study, which were featured in ...
Posted by Michael Wonder on 06 Sep 2023
FDA accepts application for Genentech’s crovalimab for the treatment of PNH, a rare life-threatening blood condition
6 September 2023 - Acceptance based on the Phase III COMMODORE 2 study, which demonstrated crovalimab achieved disease control and was ...
Posted by Michael Wonder on 06 Sep 2023
Italfarmaco Group receives EMA validation of marketing authorisation application for givinostat in Duchenne muscular dystrophy
5 September 2023 - Italfarmaco Group announced today that its marketing authorisation application for givinostat as a potential treatment for ...
Posted by Michael Wonder on 06 Sep 2023
Arcturus Therapeutics and CSL announce European Medicines Agency validates marketing authorisation application for ARCT-154 vaccine to prevent COVID-19
5 September 2023 - EMA application supported by Phase 3 primary vaccination study demonstrating primary efficacy endpoint was met. ...