Blog
RSS FeedPosted by Michael Wonder on 05 Feb 2022
TGA approves provisional determination for Gilead for COVID-19 treatment, Veklury (remdesivir), for proposed use in children and adults who are at risk of progressing to severe COVID-19
5 February 2022 - The TGA has granted a second provisional determination to Gilead in relation to its COVID-19 treatment, ...
Posted by Michael Wonder on 27 Jan 2022
TGA approves Tepmetko for patients with non-small-cell lung cancer
27 January 2022 - Tepotinib (Tepmetko) has provisional approval in Australia for the treatment of adult patients with locally advanced or ...
Posted by Michael Wonder on 20 Jan 2022
Statement on the arrival of the Novavax vaccine and COVID-19 pills
20 January 2022 - Medicines Australia welcomes the TGA’s provisional approval for the Novavax COVID-19 vaccine and the provisional approval ...
Posted by Michael Wonder on 20 Jan 2022
Two anti-viral COVID-19 treatments approved
20 January 2022 - The Australian Government welcomes the Therapeutic Goods Administration’s provisional approval of the first oral treatments for COVID-19 ...
Posted by Michael Wonder on 19 Jan 2022
TGA provisionally approves two oral COVID-19 treatments, molnupiravir (Lagevrio) and nirmatrelvir and ritonavir (Paxlovid)
20 January 2022 - The TGA has granted provisional approval to two oral COVID-19 treatments: Paxlovid (nirmatrelvir and ritonavir, Pfizer) ...
Posted by Michael Wonder on 18 Jan 2022
TGA in review (2021)
19 January 2022 - Using a liberal definition of what constitutes a 'new medicine', we have determined the TGA approved ...
Posted by Michael Wonder on 17 Jan 2022
TGA approves ‘game changing’ ovarian cancer drug bringing new hope to patients
18 January 2022 - Federal health authorities have approved a breakthrough drug for ovarian cancer, bringing a game-changing treatment option ...
Posted by Michael Wonder on 04 Jan 2022
TGA grants provisional determination to AstraZeneca for COVID-19 prophylaxis and treatment, tixagevimab and cilgavimab (Evusheld)
4 January 2022 - On 4 January 2022, the TGA granted a further provisional determination to AstraZeneca in relation to ...
Posted by Michael Wonder on 15 Dec 2021
TGA approves new medicine for paediatric cancer
15 December 2021 - Another new cancer medicine from AstraZeneca. ...
Posted by Michael Wonder on 14 Dec 2021
Access Consortium statement on COVID-19 medicines
14 December 2021 - Vaccines have played a critical role in fighting the COVID-19 pandemic. However, medicines can still play ...
Posted by Michael Wonder on 14 Dec 2021
mRNA manufacturing facility will deliver long term health benefits for Australians
14 December 2021 - Medicines Australia welcomes the announcement that Australia will manufacture mRNA vaccines in a deal struck with ...
Posted by Michael Wonder on 13 Dec 2021
ACCC helps to protect Australians against medicine shortages caused by COVID-19
10 December 2021 - Medicine shortages from the COVID-19 pandemic will continue to be actively managed by Medicines Australia and ...
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 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. ...