Blog
RSS FeedPosted 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 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 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 ...
Posted by Michael Wonder on 20 Oct 2021
TGA approves Brukinsa for another use
20 October 2021 - The second approval for zanubrutinib this month. ...
Posted by Michael Wonder on 19 Oct 2021
New medicine for breast cancer approved by the TGA
19 October 2021 - Enhertu has been approved for provisional registration. ...
Posted by Michael Wonder on 18 Oct 2021
Australia secures additional COVID-19 treatments
17 October 2021 - The Australian Government has secured access to two additional COVID-19 treatments to support the National Plan to ...
Posted by Michael Wonder on 18 Oct 2021
TGA provisional approval of Roche COVID-19 treatment, casirivimab with imdevimab (Ronapreve)
18 October 2021 - The TGA has provisionally approved the use of the Roche combination therapy, casirivimab + imdevimab (Ronapreve) ...
Posted by Michael Wonder on 07 Oct 2021
BeiGene announces first regulatory approval in Australia for Brukinsa (zanubrutinib) for treatment of patients with Waldenström’s macroglobulinaemia
7 October 2021 - Represents Brukinsa’s second recent approval in the Asia-Pacific region, following October 1 approval in Singapore for treatment ...
Posted by Michael Wonder on 07 Oct 2021
Joint statement: supply allocations of intravenous tocilizumab (Actemra) during serious shortage
7 October 2021 - Roche, the sponsor of tocilizumab (Actemra), notified the TGA of shortages of multiple presentations of tocilizumab ...
Posted by Michael Wonder on 06 Oct 2021
Australian Government buys 300,000 doses of Merck COVID-19 treatment drug molnupiravir that has not yet been approved
5 October 2021 - While Australia is still trying to reach its COVID-19 vaccination targets, treatment options for the virus ...
Posted by Michael Wonder on 06 Oct 2021
Australia secures additional supplies of sotrovimab
4 October 2021 - The Australian Government has increased supplies of the promising COVID-19 treatment sotrovimab with over 15,000 additional doses ...