5 February 2024 - GTX-102 is the first Angelman syndrome therapeutic candidate to receive PRIME designation. ...
27 November 2023 - Valneva today announced that the EMA has performed a technical validation of the marketing authorisation application ...
16 November 2023 - IRE) -- Praxis Precision Medicines today announced that the EMA has awarded its Priority Medicines (PRIME) designation ...
25 October 2023 - Valneva today announces the submission of a marketing application with the EMA for approval of the ...
24 October 2023 - PRIME designation granted based on Phase 2 ARCHER trial results, which showed meaningful preservation of visual function ...
23 October 2023 - 4D-150 combines a novel, targeted intravitreal next generation AAV vector with a dual transgene that inhibits four ...
13 October 2023 - Intellia Therapeutics today announced that the EMA has granted Priority Medicine (PRIME) designation to NTLA-2002 for ...
18 September 2023 - The EMA’s PRIME status is granted to drug candidates that may offer a major therapeutic advantage over ...
31 May 2023 - Rocket Pharmaceuticals today announced that the EMA has granted Priority Medicines (PRIME) designation to RP-A501, the ...
7 March 2023 - Genethon today announced that the EMA has granted PRIME (Priority Medicines) status to the gene therapy, ...
21 February 2023 - US FDA has set an action date for August 2023. ...
17 January 2023 - FBX-101 is granted priority medicines (PRIME) designation by the EMA after review of Phase 1/2 RESKUE clinical ...
6 January 2023 - Biologic license application designated priority review by FDA and seeks approval for rozanolixizumab for the treatment ...
8 November 2022 - The US FDA and the EMA agreed on nearly two-thirds of decisions to grant or deny ...
28 October 2022 - Application based on positive pivotal Phase 3 data showing vaccine efficacy against respiratory syncytial virus-lower respiratory tract ...