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RSS FeedPosted by Michael Wonder on 22 Feb 2024
TGA approves new medication for treatment of endometriosis symptoms
23 February 2024 - Australian drug regulator gives company green light for tablet – although it won’t be subsidised by Pharmaceutical ...
Posted by Michael Wonder on 15 Jun 2022
TGA approves Vyxeos
15 June 2022 - This marks the first TGA approval for Jazz Pharmaceuticals. ...
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 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 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 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 24 Mar 2021
Vertex receives Australian TGA approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to treat people with cystic fibrosis ages 12 years and older who have at least one F508del mutation
24 March 2021 - With this approval approximately 750 people living with cystic fibrosis in Australia will be newly eligible for ...
Posted by Michael Wonder on 12 Mar 2019
Vertex receives approval for Symdeko (tezacaftor/ivacaftor and ivacaftor) in Australia, to treat the underlying cause of cystic fibrosis in people aged 12 and older with certain CFTR gene mutations
12 March 2019 - A new treatment option for patients with two copies of the F508del mutation, the most common mutation ...
Posted by Michael Wonder on 14 Feb 2019
New weight loss pill launched in Australia
14 February 2019 - A new medication to help fight obesity has been launched in Australia. ...
Posted by Michael Wonder on 05 Dec 2016
TGA approves AbbVie's Technivie
5 December 2016 - The TGA has approved another AbbVie combination product for use by patients with chronic hepatitis C ...
Posted by Michael Wonder on 23 Nov 2016
TGA approves extended use of Harvoni
23 November 2016 - The TGÅ has approved the use of Harvoni in additional genotypes. ...
Posted by Michael Wonder on 31 Oct 2016
TGA approves new combination product for type 2 diabetes
31 October 2016 - The TGA has approved AstraZeneca's Qtern (saxagliptin hydrochloride with dapagliflozin propanediol monohydrate). ...
Posted by Michael Wonder on 21 Sep 2016
TGA publishes AusPAR for Orkambi
21 September 2016 - The TGA has published an AusPAR for Vertex's combination product for cystic fibrosis. ...
Posted by Michael Wonder on 14 Sep 2016
TGA approves Odefsey
30 August 2016 - The TGA has approved Gilead's combination product for HIV-1 infection Odefsey. ...
Posted by Michael Wonder on 31 Aug 2016
TGA approves Zepatier
31 August 2016 - The TGA has approved MSD's Zepatier (grazoprevir with elbasvir). ...