Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 27 Jul 2022
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) in Crohn's disease
27 July 2022 - Submissions are supported by three Phase 3 clinical trials demonstrating upadacitinib achieved the co-primary endpoints of clinical ...
Posted by Michael Wonder on 25 Jul 2022
Applications for proposed first of a kind multiple sclerosis biosimilar natalizumab accepted by US FDA and EMA
25 July 2022 - Submission of proposed biosimilar supported by comprehensive package; aims to expand treatment access for people with multiple ...
Posted by Michael Wonder on 20 Jul 2022
Pfizer and BioNTech complete submission to European Medicines Agency for Omicron BA.1 adapted bivalent vaccine candidate
19 July 2022 - Pfizer and BioNTech today announced they have completed a submission to the EMA for an Omicron-adapted bivalent ...
Posted by Michael Wonder on 19 Jul 2022
Genmab announces that AbbVie will submit marketing authorisation application to EMA for epcoritamab for the treatment of relapsed/refractory diffuse large B-cell lymphoma
18 July 2022 - Genmab today announced that AbbVie will submit a conditional marketing authorisation application with the EMA for ...
Posted by Michael Wonder on 19 Jul 2022
EU regulator reviews Pfizer-BioNTech COVID shot in children as young as 6 months
18 July 2022 - The European Medicines Agency on Monday started reviewing a low-dose version of BioNTech and Pfizer’s COVID-19 ...
Posted by Michael Wonder on 18 Jul 2022
EMA validates marketing authorisation application for trastuzumab duocarmazine (SYD985) in HER2 positive metastatic breast cancer
18 July 2022 - Submission follows positive results of Phase 3 TULIP trial. ...