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 ...

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TGA approves Rybelsus

22 February 2022 - Rybelsus is a new formulation of semaglutide. ...

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Empaveli approved by the TGA

17 February 2022 - First TGA approval for newcomer Apellis. ...

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Moderna's COVID-19 vaccine (Spikevax) provisionally approved for use in individuals 6 years and older

17 February 2022 - The TGA has provisionally approved the Moderna COVID-19 vaccine, Spikevax, for use in individuals aged 6 ...

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TGA provisionally approves AstraZeneca's COVID-19 vaccine as booster dose

9 February 2022 - On 8 February 2022, the TGA provisionally approved a booster dose of the AstraZeneca COVID-19 vaccine, Vaxzevria, ...

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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, ...

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Pfizer's COVID-19 vaccine (Comirnaty) provisionally approved for use as a booster in individuals aged 16-17 years old

28 January 2022 - The Therapeutic Goods Administration has provisionally approved the Pfizer COVID-19 vaccine, Comirnaty for use as a ...

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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 ...

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TGA approves MSD's Vaxneuvance

24 January 2022 - Vaxneuvance (pneumococcal 15 valent conjugate vaccine (CRM197 protein)) was approved on 17 January 2022 for active ...

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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 ...

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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 ...

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TGA provisionally approves Novavax (Biocelect) COVID-19 vaccine Nuvaxovid

20 January 2022 - The Therapeutic Goods Administration has granted provisional approval to Biocelect (on behalf of Novavax) for its ...

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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) ...

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Lieutenant General John Frewen says he expects TGA approval of Novavax vaccine is 'imminent'

19 January 2022 - The head of Australia's vaccine rollout expects one to two per cent of Australians who remain unvaccinated ...

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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 ...

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