26 March 2024 - Over 30 years ago, Gregg Gonsalves and other AIDS activists persuaded Congress to create the accelerated ...
4 March 2024 - The new PDUFA action date set by the FDA is 21 September 2024. ...
13 February 2024 - New Prescription Drug User Fee Act date of 30 June 2024. ...
25 January 2024 - Liquidia announced today that the US FDA provided an update on its review of the new drug ...
23 January 2024 - FDA continues to review the file past the Prescription Drug User Fee Act goal date of ...
29 November 2023 - Italfarmaco Group announced today that the US FDA has extended the review process of the n ...
15 November 2023 - The FDA’s top cancer drug regulator doesn’t always ask for permission before taking on big initiatives. ...
2 November 2023 - PDUFA target action date of 5 April 2024. ...
17 October 2023 - Mirum Pharmaceuticals today announced that the US FDA has extended the review of the supplemental new drug ...
20 September 2023 - Alvotech announced today that the US FDA has accepted Alvotech’s resubmitted biologics license application for AVT02, a ...
19 September 2023 - UCB today provided an update on the biologics license application for bimekizumab for the treatment of ...
14 September 2023 - FDA extends PDUFA date to 24 February 2024 on resource constraints and agrees to work with ...
29 August 2023 - Formycon and its license partner Klinge Biopharma announce that the US FDA has accepted the biologics license ...
11 September 2023 - PDUFA target goal date set for 28 April 2024. ...
11 September 2023 - PDUFA target action date of 26 June 2024. ...