15 December 2023 - New drug application is supported by data evaluating seladelpar efficacy and safety in over 500 patients. ...
14 December 2023 - These regulatory milestones bring CSL one step closer to delivering on our promise to patients with ...
13 December 2023 - FDA target action date is 12 June 2024. ...
12 December 2023 - Filing marks first NDA submission for any psychedelic-assisted therapy. ...
12 December 2023 - BLA supported by results from Phase 2/3 clinical trial and outcomes of real-world use of the human ...
11 December 2023 - Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend ...
11 December 2023 - PDUFA goal date is 14 May 2024. ...
6 December 2023 - July 19, 2024 PDUFA target action date assigned by the FDA. ...
6 December 2023 - First BLA for an engineered T-cell therapy for solid tumours submitted to US FDA. ...
7 December 2023 - Alpha Cognition is pleased to announce that the US FDA has completed its filing review and has ...
7 December 2023 - New drug application granted priority review with PDUFA date set for 10 June 2024. ...
5 December 2023 - NDA submission is based on positive results from ATTRibute-CM Phase 3 study. ...
5 December 2023 - Crinecerfont new drug application submission planned in 2024. ...
5 December 2023 - The US FDA assigned a target action date of 5 April 2024. ...
4 December 2023 - Vanda Pharmaceuticals today announced that the US FDA has accepted the filing of Vanda's new drug ...