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 ...

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TGA approves new medicine for paediatric cancer

15 December 2021 - Another new cancer medicine from AstraZeneca. ...

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TGA approves booster doses of the Moderna COVID-19 vaccine Spikevax

8 December 2021 - The TGA has provisionally approved a booster dose of the Moderna COVID-19 vaccine, SPIKEVAX, for individuals ...

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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 ...

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Pfizer's COVID-19 vaccine (Comirnaty) provisionally approved for use in individuals 5 years and over

5 December 2021 - The TGA has provisionally approved the Pfizer COVID-19 vaccine, Comirnaty, for use in individuals 5 years ...

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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 ...

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TGA approves Nexviazyme

1 December 2021 - Avalglucosidase alfa (Nexviazyme) is a recombinant form of human acid α-glucosidase. ...

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TGA approves Bayer's Verquvo

29 November 2021 - Verquvo has been approved under the Black Triangle Scheme. ...

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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. ...

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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 ...

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TGA grants provisional determination to Grand Pacific for its COVID-19 protein-based subunit vaccine

22 November 2021 - The Therapeutic Goods Administration has granted provisional determination to Grand Pacific CRO (the Australian sponsor acting ...

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Moderna's COVID-19 vaccine (Spikevax) - provisional determination granted for proposed use in children and booster shot for adults under evaluation

10 November 2021 - The TGA has granted a provisional determination to Moderna in relation to its COVID-19 vaccine, Spikevax. ...

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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 ...

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TGA approves Illuccix for prostate cancer imaging

2 November 2021 - Telix is delighted to announce that the TGA has approved Illuccix (kit for the preparation of ...

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TGA recognises two more COVID-19 vaccines not registered in Australia but used widely internationally

1 November 2021 - Today, the TGA determined that Covaxin (manufactured by Bharat Biotech, India) and BBIBP-CorV (manufactured by Sinopharm, China) ...

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