Blog
RSS FeedPosted by Michael Wonder on 08 Dec 2021
TGA approves booster doses of the Moderna COVID-19 vaccine Spikevax
8 December 2021 - The TGA has provisionally approved a booster dose of the Moderna COVID-19 vaccine, SPIKEVAX, for individuals ...
Posted by Michael Wonder on 08 Dec 2021
Improvements to clinical trials will strengthen Australia’s economy and benefit patients
8 December 2021 - Clinical trials in Australia need improvements if we are to increase our global competitiveness says Medicines ...
Posted by Michael Wonder on 06 Dec 2021
TGA provisional approval of Celltrion COVID-19 treatment regdanvimab (Regkirona)
6 December 2021 - On 6 December 2021, the TGA granted provisional approval to Celltrion Healthcare for the use of ...
Posted by Michael Wonder on 04 Dec 2021
Pfizer's COVID-19 vaccine (Comirnaty) provisionally approved for use in individuals 5 years and over
5 December 2021 - The TGA has provisionally approved the Pfizer COVID-19 vaccine, Comirnaty, for use in individuals 5 years ...
Posted by Michael Wonder on 03 Dec 2021
ATAGI update following weekly COVID-19 meeting (1 December 2021)
3 December 2021 - On 1 December 2021 ATAGI reviewed the latest developments relating to COVID-19 and COVID-19 vaccine safety. ...
Posted by Michael Wonder on 02 Dec 2021
COVID-19 vaccine weekly safety report (2 December 2021)
2 December 2021 - To 28 November 2021, the TGA has received 354 reports which have been assessed as likely to ...
Posted by Michael Wonder on 02 Dec 2021
TGA provisional approval of Roche COVID-19 treatment, tocilizumab (Actemra)
1 December 2021 - On 1 December 2021, the TGA granted provisional approval to Roche for the use of tocilizumab ...
Posted by Michael Wonder on 01 Dec 2021
TGA approves Nexviazyme
1 December 2021 - Avalglucosidase alfa (Nexviazyme) is a recombinant form of human acid α-glucosidase. ...
Posted by Michael Wonder on 29 Nov 2021
TGA approves Bayer's Verquvo
29 November 2021 - Verquvo has been approved under the Black Triangle Scheme. ...
Posted by Michael Wonder on 29 Nov 2021
TGA approves new medicines for patients with graft versus host disease
26 November 2021 - Rholistiq is Kadmon's first product to be approved in Australia. ...
Posted by Michael Wonder on 29 Nov 2021
Mayne Pharma and Mithra announce TGA approval of Nextstellis oral contraceptive
29 November 2021 - Mayne Pharma and Mithra Pharmaceuticals are very pleased to announce the TGA has approved the novel combined ...
Posted by Michael Wonder on 25 Nov 2021
COVID-19 vaccine weekly safety report (25 November 2021)
25 November 2021 - To 21 November 2021, the TGA has received 341 reports which have been assessed as likely to ...
Posted by Michael Wonder on 24 Nov 2021
COVID-19 vaccine indemnity
24 November 2021 - The Australian Government is reducing the claim threshold of the no fault COVID-19 Vaccine Claims Scheme to ...
Posted by Michael Wonder on 24 Nov 2021
Review of real world evidence and patient reported outcomes
24 November 2021 - The TGA recently commissioned a review into its usage of real world evidence and patient reported ...
Posted by Michael Wonder on 22 Nov 2021
TGA grants provisional determination to Grand Pacific for its COVID-19 protein-based subunit vaccine
22 November 2021 - The Therapeutic Goods Administration has granted provisional determination to Grand Pacific CRO (the Australian sponsor acting ...