28 December 2020 - Marketing authorisation application is supported by positive results from the pivotal Phase 3 True North trial evaluating ...
14 November 2019 - The Department of Health (the Department) has been working to digitise and simplify the PBS submission ...
25 July 2019 - From 1 August 2019, hospital authorities will no longer be required to seek separate approval from ...
14 May 2019 - The list includes a number of medicines for patients with breast cancer. ...
27 February 2019 - Bayer today announced the completion of the rolling submission of a new drug application for darolutamide to ...
7 January 2019 - The PBAC considered 195 submissions in 2018; 173 were considered by the PBAC in 2017. ...
3 May 2018 - New Zealand infants suffering from a rare neuromuscular condition may soon be eligible for compassionate access ...
8 March 2018 - Operational change can help reduce the time between regulatory approval and reimbursement recommendations for prescription drugs ...
13 November 2017 - All resubmissions that are filed by manufacturers on or after 2 January 2018 will be subject to ...
13 November 2017 - In August 2017, CADTH invited stakeholder comments and feedback on a proposal to revise the resubmission requirements ...
10 November 2017 - Sunovion Pharmaceuticals today announced that the U.S. FDA has accepted for review the new drug application ...
9 November 2017 - Tolvaptan has been studied in patients with autosomal dominant polycystic kidney disease in a clinical trial program ...
7 November 2017 - Biocon´s partner Mylan has resubmitted the marketing authorisation applications for our proposed biosimilar trastuzumab and pegfilgrastim with ...
7 November 2017 - GlaxoSmithKline today announced the submission of a supplemental biologics license application to the United States FDA, ...
6 November 2017 - The application for marketing approval is based on the COMPASS study. ...