12 June 2023 - Decision based on CAPItello-291 Phase 3 trial results which showed the combination reduced the risk of ...
1 June 2023 - Pharming announces that it has entered into a definitive agreement with Novartis to sell its rare ...
26 May 2023 - Priority review granted with PDUFA action date of 25 November 2023. ...
25 May 2023 - PDUFA target action date set for 30 November 2023. ...
23 May 2023 - CAMPSIITE trial is enrolling mucopolysaccharidosis type II patients as part of a pivotal program that incorporates ...
23 May 2023 - Rocket Pharmaceuticals today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...
16 May 2023 - FDA has granted TAK-755 priority review and rare paediatric disease designation, as well as fast track designation ...
15 May 2023 - SiSaf announces that SIS-101-ADO, its siRNA therapeutic, has been granted orphan drug designation and rare paediatric disease ...
4 May 2023 - HAV granted second RMAT designation by the FDA. ...
5 March 2023 - Priority Review accelerates FDA review time with a PDUFA target action on 6 July 2023. ...
2 March 2023 - PDUFA date is 21 June 2023. ...
23 February 2023 - BLA supported by two pivotal trials demonstrating non-inferior vision gains to Eylea (aflibercept) Injection, with vast majority ...
21 February 2023 - US FDA has set an action date for August 2023. ...
21 February 2023 - If approved, pozelimab would be the first and only treatment for those living with CHAPLE. ...
20 February 2023 - Azafaros today announced its progress in on-going interactions with health authorities regarding its lead asset, AZ-3102. ...