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 ...
4 December 2023 - Celltrion announced on 30 November (local time) that it has completed the application for product licensing ...
29 November 2023 - Italfarmaco Group announced today that the US FDA has extended the review process of the n ...
30 November 2023 - Acceptance based on results from the Phase 3 KEYNOTE-A39 trial, which showed a statistically significant and ...
30 November 2023 - Results of pivotal confirmatory trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall survival and ...
30 November 2023 - Formycon and its commercialisation partner Fresenius Kabi today announced that the US FDA has accepted the biologics ...