Blog
RSS FeedPosted by Michael Wonder on 12 Jul 2023
Idefirix (imlifidase) receives provisional approval in Australia as desensitisation treatment in highly sensitised patients prior to kidney transplantation
11 July 2023 - Regulatory milestone marks the first time Idefirix has been approved in kidney transplantation from both living ...
Posted by Michael Wonder on 10 Jul 2023
TGA decision on access to medical terminations
11 July 2023 - The Government welcomes the TGA’s decision to remove a number of restrictions on health professionals who ...
Posted by Michael Wonder on 06 Jul 2023
Moderna announces global regulatory submissions for its respiratory syncytial virus (RSV) vaccine, mRNA-1345
5 July 2023 - Moderna has submitted marketing authorization applications for the investigational RSV vaccine, mRNA-1345, with the European Medicines Agency, ...
Posted by Michael Wonder on 29 Jun 2023
Lymphoma therapy now approved for Australian patients with diffuse large B-cell lymphoma
28 June 2023 - Recent five-year follow-up data from Phase 2 L-MIND investigation showed patients treated with Minjuvi had prolonged, ...
Posted by Michael Wonder on 06 Jun 2023
‘Future of cancer treatment’ has just been approved
6 June 2023 - Australian scientists pioneering a new type of therapy, which re-engineers a patient’s own T-cells, could result in ...
Posted by Michael Wonder on 04 Jun 2023
TGA supports MHRA’s new international recognition framework for medicines
2 June 2023 - As a trusted regulatory partner, TGA is committed to support the new international recognition framework that MHRA ...
Posted by Michael Wonder on 31 May 2023
TGA approves pathway for more plasma donors
30 May 2023 - The Government welcomes the Therapeutic Goods Administration’s approval of a ‘plasma pathway’, allowing a larger pool of ...
Posted by Michael Wonder on 30 May 2023
‘A victim of its own success’: inside the great Ozempic shortage
26 May 2023 - The drug is approved in Australia to treat type 2 diabetes but people have flocked to it ...
Posted by Michael Wonder on 30 May 2023
ATAGI advice on the preferential use of bivalent COVID-19 vaccines for primary vaccination of people aged 12 years or older
30 May 2023 - ATAGI has made recommendations on the use of bivalent COVID-19 vaccines as a primary course. ...
Posted by Michael Wonder on 27 Apr 2023
Moderna’s COVID-19 vaccine Spikevax receives approval for full registration
24 April 2023 - On 21 April, the TGA approved Moderna Australia’s application to transition its COVID-19 vaccine, Spikevax (elasomeran), ...
Posted by Michael Wonder on 10 Apr 2023
COVID-19 vaccine safety report (6 April 2023)
6 April 2023 - To 2 April 2023, more than 44 million doses of Comirnaty (Pfizer) mRNA vaccines have been administered in ...
Posted by Michael Wonder on 06 Apr 2023
AstraZeneca vaccine discontinued by Federal Government
5 April 2023 - One of the first COVID-19 jabs offered to Australians has been quietly discontinued, the Federal Government has ...
Posted by Michael Wonder on 27 Mar 2023
TGA’s new powers will help reduce the impact of medicine shortages on patients
24 March 2023 - From 22 March 2023, the TGA can approve the temporary import or supply of an overseas approved ...
Posted by Michael Wonder on 27 Mar 2023
COVID-19 vaccine safety report (23 March 2023)
23 March 2023 - To 19 March 2023, more than 44 million doses have been administered in Australia, as well ...
Posted by Michael Wonder on 25 Mar 2023
Lapse of provisional registration for Tecentriq (atezolizumab) for the treatment of locally advanced or metastatic triple negative breast cancer
22 March 2023 - On 22 March 2023, the provisional registration of Tecentriq (atezolizumab) for the treatment of mTNBC will ...