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RSS FeedPosted by Michael Wonder on 25 Feb 2022
TGA provisionally approves AstraZeneca's combination therapy (tixagevimab and cilgavimab, Evusheld) - for pre-exposure prevention (prophylaxis) of COVID-19
25 February 2022 - On 24 February 2022, the TGA granted provisional approval to AstraZeneca for its tixagevimab and cilgavimab ...
Posted by Michael Wonder on 22 Feb 2022
Controversial Alzheimer’s drug under TGA review ‘should not be approved’
21 February 2022 - Patients will be put at risk and taxpayers will face a significant economic burden if aducanumab receives ...
Posted by Michael Wonder on 22 Feb 2022
TGA approves Rybelsus
22 February 2022 - Rybelsus is a new formulation of semaglutide. ...
Posted by Michael Wonder on 17 Feb 2022
Empaveli approved by the TGA
17 February 2022 - First TGA approval for newcomer Apellis. ...
Posted by Michael Wonder on 14 Feb 2022
Anxiety mounts for Australian patients as supply chain crunch hits another arthritis drug
14 February 2022 - Patients are reckoning with major shortages of a second rheumatoid arthritis drug in Australia, with manufacturing ...
Posted by Michael Wonder on 09 Feb 2022
Evolus receives acceptance of submission in Australia, a pivotal step in approval process for Nuceiva
8 February 2022 - Evolus today announced the acceptance of its submission to the Australian TGA for regulatory approval of Nuceiva ...
Posted 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. ...