Blog
RSS FeedPosted by Michael Wonder on 14 Apr 2021
TGA accepts Telix’s prostate cancer imaging product submission and commences priority evaluation process
14 April 2021 - Telix is pleased to announce that the TGA has accepted the Company’s submission for the registration ...
Posted by Michael Wonder on 08 Dec 2020
Telix granted TGA priority review for prostate cancer imaging
7 December 2020 - Telix announces today that the Company’s preliminary application to the TGA for TLX591-CDx was made at ...
Posted by Michael Wonder on 31 Mar 2020
Expedited COVID-19 medical device application process
31 March 2020 - The Therapeutic Goods Administration is currently undertaking an expedited assessment process for all medical devices associated with ...
Posted by Michael Wonder on 12 Mar 2020
Therapeutic Goods Administration prepare to fast track coronavirus vaccines and treatment
11 March 2020 - The Therapeutic Goods Administration is gearing up to fast track the approval of any vaccines or treatments ...
Posted by Michael Wonder on 25 Nov 2019
Acalabrutinib receives TGA approval for CLL and SLL cancers
25 November 2019 - The Therapeutic Goods Administration has approved the use of acalabrutinib (Calquence) for the treatment of patients ...
Posted by Michael Wonder on 01 Aug 2019
Fast track pathways for drug approvals: the Australian experience so far
1 August 2019 - In 2016, the Australian Government announced that the Therapeutic Goods Administration would establish two new pathways ...
Posted by Michael Wonder on 10 Jul 2018
Medicines Australia welcomes priority review pathway programme milestone
10 July 2018 - Last week saw the listing of Eryland (apalutamide) for the treatment men with non-metastatic (castration-resistant) prostate ...
Posted by Michael Wonder on 01 May 2018
Opdivo (nivolumab) is the first and only anti-PD-1 therapy approved by TGA for adjuvant treatment of melanoma
30 April 2018 - Opdivo now approved in Australia for nine indications across six cancer areas in under three years. ...
Posted by Michael Wonder on 07 Feb 2018
Priority review pathway - first registration decision
6 February 2018 - Alectinib hydrochloride (Alecensa) is the first medicine to be registered on the Australian Register of Therapeutic ...
Posted by Michael Wonder on 28 Jun 2017
J&J, Medtronic push back against TGA priority review proposal
21 June 2017 - Johnson & Johnson and Medtronic are pushing back against the Australian TGA’s proposed priority review pathway ...
Posted by Michael Wonder on 26 Jun 2017
Priority review pathway: prescription medicines
26 June 2017 - As part of the Government's response to the Review of Medicines and Medical Devices Regulation (MMDR review), ...