Blog
RSS FeedPosted by Michael Wonder on 21 Jul 2022
TGA approves Padcev
21 July 2022 - Enfortumab vedotin is an antibody-drug conjugate targeting nectin-4, an adhesion protein located on the surface of epithelial ...
Posted by Michael Wonder on 28 Feb 2022
Prescription medicines: applications under evaluation (February 2022)
25 February 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...
Posted by Michael Wonder on 07 Sep 2021
TGA approves new cancer medicine
7 September 2021 - Luspatercept (Reblozyl) is used to treat patients with certain transfusion-dependent anaemias. ...
Posted by Michael Wonder on 23 May 2021
Prescription medicines: applications under evaluation (May 2021 update)
21 May 2021 - The TGA has updated its list of applications for new medicines or new uses for existing ...
Posted by Michael Wonder on 22 Apr 2021
TGA publishes AusPAR for Zolgensma
22 April 2021 - Rapid publication following approval. ...
Posted by Michael Wonder on 01 Feb 2021
When is a medicine currently under review by the TGA not under evaluation?
1 February 2021 - The approval of the first new medicine for 2021 raises an interesting question. ...
Posted by Michael Wonder on 21 Jul 2020
TGA publishes AusPAR for Vemlidy
21 July 2020 - AusPAR published within days of its provisional registration; why do other take years? ...
Posted by Michael Wonder on 28 Aug 2019
Australian Public Assessment Reports for prescription medicines
28 August 2019 - TGA is reviewing the operation of transparency measures and are considering activities to increase transparency of ...
Posted by Michael Wonder on 03 Dec 2018
Zambon announces approval and ARTG listing of safinamide in Australia for treatment of patients with Parkinson’s disease
30 November 2018 - Further regulatory submissions on-going with authorities worldwide. ...
Posted by Michael Wonder on 03 Nov 2017
AusPAR content, January 2018: registration timelines
3 November 2017 - The content of AusPARs will be updated to provide increased transparency of TGA's evaluation process through ...
Posted by Michael Wonder on 29 Nov 2016
TGA publishes AusPAR for Spiriva Respimat
29 November 2015 - AusPAR published 18 months after registration. ...
Posted by Michael Wonder on 28 Nov 2016
AusPARs: questions & answers
28 November 2016 - The TGA provides transparency of the prescription medicines registration process via the online publication of Australian Public ...
Posted by Michael Wonder on 23 Nov 2016
AusPAR user survey results
23 November 2016 - The survey was to help the TGA identify the audience for AusPARs, understand what AusPARs were being ...
Posted by Michael Wonder on 02 Nov 2016
TGA publishes AusPAR for Esmya
2 November 2016 - The TGA has published an AusPAR for Vifor Pharma's Esmya. ...
Posted by Michael Wonder on 18 Oct 2016
TGA publishes AusPAR for Keytruda
18 October 2016 - The TGA has finally published an AusPAR for MSD's PD-1 inhibitor. ...