2 July 2024 - The FDA’s rare paediatric disease priority review voucher program, which has been providing incentives for lifesaving innovations ...
2 July 2024 - Vanza triple granted priority review with a PDUFA target action date of 2 January 2025. ...
1 July 2024 - PDUFA target action dates in late December 2024. ...
1 July 2024 - Submission based on positive SUPERNOVA Phase 3 trial data which demonstrated a statistically significant reduction in ...
26 June 2024 - Olezarsen PDUFA date set for 19 December 2024 for treatment of familial chylomicronemia syndrome. ...
25 June 2024 - ExCellThera announced today that the market authorisation application for UM171 cell therapy (INN-dorocubicel) has been accepted under ...
24 June 2024 - Sellas Life Sciences today announced that the US FDA has granted rare paediatric disease designation to SLS009, ...
20 June 2024 - Priority review granted with a PDUFA goal date set for 17 December 2024. ...
19 June 2024 - First allogeneic cell therapy to receive both FDA designations for the treatment of corneal oedema secondary to ...
18 June 2024 - Race Oncology is pleased to announce that the US FDA has extended rare paediatric disease designation ...
7 June 2024 -- Calico Life Sciences today announced that its investigational eIF2B activator fosigotifator (ABBV-CLS-7262) has been accepted into ...
10 June 2024 - Decision based on LAURA Phase 3 trial results which extended median progression-free survival by more than ...
31 May 2024 - Regenerative Medicine Advanced Therapy designation follows phase I clinical trial results demonstrating that bemdaneprocel is well tolerated ...
3 June 2024 - NGN-401 is one of only three CBER programs chosen by FDA. ...
3 June 2024 - START is a pilot program newly launched jointly by the FDA CDER and CBER divisions to further ...