23 August 2022 - Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy ...
19 August 2022 - Elacestrant, if approved, would be the first oral selective oestrogen receptor degrader to be available for patients ...
22 August 2022 - A review decision by the EMA is expected in the second half of 2023. ...
22 August 2022 - The EMA filing is supported by the pivotal ReSTORE Phase 3 clinical trial results, where rezafungin demonstrated ...
18 August 2022 - Fresenius Kabi announced today that its marketing authorisation application for MSB11456, the company’s tocilizumab biosimilar candidate, ...
18 August 2022 - Aeglea BioTherapeutics today announced that a marketing authorisation application for pegzilarginase for the treatment of arginase 1 ...
9 August 2022 - The EMA has started a rolling review of a variant-adapted COVID-19 vaccine from Pfizer and BioNTech, ...
1 August 2022 - SK bioscience will accelerate to apply for emergency use listing to the World Health Organization. ...
27 July 2022 - The EMA’s Emergency Task Force has started a review of data on the use of sabizabulin ...
27 July 2022 - Submissions are supported by three Phase 3 clinical trials demonstrating upadacitinib achieved the co-primary endpoints of clinical ...
25 July 2022 - Submission of proposed biosimilar supported by comprehensive package; aims to expand treatment access for people with multiple ...
19 July 2022 - Pfizer and BioNTech today announced they have completed a submission to the EMA for an Omicron-adapted bivalent ...
18 July 2022 - Genmab today announced that AbbVie will submit a conditional marketing authorisation application with the EMA for ...
18 July 2022 - The European Medicines Agency on Monday started reviewing a low-dose version of BioNTech and Pfizer’s COVID-19 ...
18 July 2022 - Submission follows positive results of Phase 3 TULIP trial. ...