1 July 2025 - We’re improving our processes, so that people can understand the outcome of expert advice to PHARMAC earlier. ...
17 June 2025 - The US FDA today announced its Commissioner’s National Priority Voucher program to enhance the health interests of ...
13 June 2025 - Agency indicates anticipated decision within four weeks ...
14 May 2025 - Troriluzole would be the first and only FDA approved treatment for spinocerebellar ataxia, if approved. ...
15 April 2025 - Eli Lilly says it could pull tens of millions of dollars invested in Australian clinical trials unless ...
3 April 2025 - Associate Health Minister David Seymour is welcoming Cabinet’s decision to enable medicines to be approved in ...
23 January 2025 - New PDUFA action date of 29 April 2025, allows FDA additional time to complete review. ...
18 January 2025 - Potentially life-saving treatments delayed by bureaucracy, doctors say. ...
13 January 2025 - Foresee Pharmaceuticals announces that the US FDA issued a Day 74 letter. ...
23 December 2024 - New drug application based on two statistically significant Phase 3 studies of TNX-102 SL for the ...
10 December 2024 - Theratechnologies today announced that the US FDA has assigned a PDUFA goal date of 25 March ...
9 December 2024 - CHMP opinion now expected in Q1, 2025. ...
26 November 2024 - PDUFA target action date extended by three months to 27 March 2025. ...
30 November 2024 - Threats and delays to affordable medicine access underscore an appetite for higher health spending, with polling placing ...
11 November 2024 - FDA sets PDUFA action date of 28 June 2025. ...