12 September 2022 - Prescription Drug User Fee Act action date set for 12 March 2023. ...
12 September 2022 - FDA grants priority review designation with PDUFA date in the first half of 2023. ...
30 August 2022 - Priority review based on pivotal data from the XTEND-1 Phase 3 study. ...
23 August 2022 - GTP-506, a potential single-dose gene editing therapy designed to restore metabolic function in patients suffering with OTC ...
16 August 2022 - First PARP inhibitor to demonstrate clinical benefit in combination with a new hormonal agent irrespective of ...
11 August 2022 - US FDA has assigned a Prescription Drug User Fee Act date of 17 February 2023. ...
1 August 2022 - PDUFA target action date is 30 January 2023. ...
25 July 2022 - Application being evaluated under FDA Real-Time Oncology Review and Project Orbis. ...
19 July 2022 - PDUFA target action date is 26 November 2022. ...
14 July 2022 - Marinus Pharmaceuticals today announced that it has entered into a definitive agreement to sell its rare ...
6 July 2022 - Kazia Therapeutics is pleased to announce that the U.S. FDA has awarded rare paediatric disease designation ...
6 July 2022 - Application is based on results from the pivotal Phase I/II study showing mosunetuzumab induced high and durable ...
6 July 2022 - Eisai and Biogen announced today that the U.S. FDA has accepted the biologics license application under the ...
29 June 2022 - Ipsen today announced that the U.S. FDA has accepted for priority review its resubmitted new drug ...
24 June 2022 - Emergent BioSolutions announced today that the U.S. FDA accepted for review the biologics license application for AV7909 ...