30 November 2023 - The Government has today tabled its response to an inquiry considering how to give Australian patients timely ...
20 November 2023 - NICE’s methods and processes for evaluating new treatments for use in the NHS are appropriate for the ...
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 ...
16 October 2023 - European Union regulators have delayed a decision to give approval for Novavax's variant-tailored COVID-19 vaccine, the ...
11 October 2023 - On 29 August 2023, the Biden administration announced the first 10 drugs selected for Medicare price ...
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. ...
22 August 2023 - Geron Corporationtoday announced that the US FDA has assigned a standard review and a PDUFA action date ...
21 August 2023 - While lagging other regulators in bringing new drugs to market, Swiss regulators say their review times ...