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RSS FeedPosted by Michael Wonder on 07 Sep 2022
EMA refused rolling review of SK Bioscience's COVID-19 vaccine
7 September 2022 - The EMA refused a rolling review of SK Bioscience's COVID-19 vaccine, SKYCovine, due to “changing pandemic ...
Posted by Michael Wonder on 06 Sep 2022
Sanofi sees EU regulatory decision on its COVID booster in weeks
5 September 2022 - The European Union's drugs regulator may be a few weeks from deciding whether to approve the ...
Posted by Michael Wonder on 30 Aug 2022
EMA announces withdrawal of two submissions for cancer medicines
30 August 2022 - The information is somewhat buried on the EMA website. ...
Posted by Michael Wonder on 27 Aug 2022
Pfizer and BioNTech complete submission to EMA for Omicron BA.4/BA.5 adapted bivalent vaccine
26 August 2022 - Submission follows application for Omicron BA.1 adapted bivalent vaccine submitted in July. ...
Posted by Michael Wonder on 25 Aug 2022
AB Science announces that it has filed an application for conditional marketing authorisation to EMA for masitinib in the treatment of ALS
24 August 2022 - AB Science today announced that it has filed an application for conditional marketing authorisation to the EMA ...
Posted by Michael Wonder on 23 Aug 2022
European Medicines Agency commences review of oral fixed-dose combination of decitabine and cedazuridine for the treatment of adults with acute myeloid leukaemia
22 August 2022 - Otsuka and Astex Pharmaceuticals today announce that the EMA has accepted the marketing authorisation application for the ...
Posted by Michael Wonder on 23 Aug 2022
Quizartinib marketing authorisation application validated by EMA for treatment of adult patients with newly diagnosed FLT3- ITD positive acute myeloid leukaemia
23 August 2022 - Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy ...
Posted by Michael Wonder on 23 Aug 2022
Menarini Group’s elacestrant marketing authorisation application accepted for review by the EMA for the treatment of ER+/HER2- advanced or metastatic breast cancer
19 August 2022 - Elacestrant, if approved, would be the first oral selective oestrogen receptor degrader to be available for patients ...
Posted by Michael Wonder on 22 Aug 2022
CSL Vifor and Travere Therapeutics announce EMA has accepted for review the conditional marketing authorisation application for sparsentan for the treatment of IgA nephropathy
22 August 2022 - A review decision by the EMA is expected in the second half of 2023. ...
Posted by Michael Wonder on 22 Aug 2022
European Medicines Agency accepts rezafungin marketing authorisation application for the treatment of invasive candidiasis
22 August 2022 - The EMA filing is supported by the pivotal ReSTORE Phase 3 clinical trial results, where rezafungin demonstrated ...
Posted by Michael Wonder on 20 Aug 2022
Fresenius Kabi announces acceptance of its marketing authorisation application by the European Medicines Agency for MSB11456, a tocilizumab biosimilar candidate
18 August 2022 - Fresenius Kabi announced today that its marketing authorisation application for MSB11456, the company’s tocilizumab biosimilar candidate, ...
Posted by Michael Wonder on 19 Aug 2022
Aeglea BioTherapeutics announces European Medicines Agency validation of marketing authorisation application for pegzilarginase for the treatment of arginase 1 deficiency
18 August 2022 - Aeglea BioTherapeutics today announced that a marketing authorisation application for pegzilarginase for the treatment of arginase 1 ...
Posted by Michael Wonder on 10 Aug 2022
EU regulator begins review of Pfizer-BioNTech's variant adapted COVID shot
9 August 2022 - The EMA has started a rolling review of a variant-adapted COVID-19 vaccine from Pfizer and BioNTech, ...
Posted by Michael Wonder on 02 Aug 2022
SK bioscience submits application for conditional marketing authorisation of COVID-19 vaccine, SKYCovion to European Medicines Agency
1 August 2022 - SK bioscience will accelerate to apply for emergency use listing to the World Health Organization. ...
Posted by Michael Wonder on 28 Jul 2022
EMA reviewing data on sabizabulin for COVID-19
27 July 2022 - The EMA’s Emergency Task Force has started a review of data on the use of sabizabulin ...