Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 20 Nov 2021
COVID-19 vaccine weekly safety report (18 November 2021)
18 November 2021 - To 14 November 2021, about 23.4 million doses of Comirnaty (Pfizer) have been administered in Australia. ...
Posted by Michael Wonder on 11 Nov 2021
Moderna booster progress ‘well advanced’ as regulator considers child vaccines
11 November 2021 - Moderna’s coronavirus vaccine could be approved for use as a booster within weeks and the medical ...
Posted by Michael Wonder on 11 Nov 2021
COVID-19 vaccine weekly safety report (11 November 2021)
11 November 2021 - To 7 November 2021, the TGA has received 288 reports which have been assessed as likely to ...
Posted by Michael Wonder on 10 Nov 2021
Why TGA head John Skerritt must go over vaccine claim
10 November 2021 - The head of the TGA must resign or be sacked over his claims about the Moderna vaccine. ...
Posted by Michael Wonder on 10 Nov 2021
Moderna's COVID-19 vaccine (Spikevax) - provisional determination granted for proposed use in children and booster shot for adults under evaluation
10 November 2021 - The TGA has granted a provisional determination to Moderna in relation to its COVID-19 vaccine, Spikevax. ...
Posted by Michael Wonder on 09 Nov 2021
Australia to wait for data from US children before clearing vaccine here
10 November 2021 - Australia’s top immunisation advisers will wait on safety data from at least several hundred thousand young ...
Posted by Michael Wonder on 09 Nov 2021
TGA grants provisional determination to AstraZeneca for COVID-19 preventative treatment, tixagevimab and cilgavimab (Evusheld)
9 November 2021 - On 4 November 2021, the TGA granted provisional determination to AstraZeneca in relation to the COVID-19 treatment ...