Australia's TGA grants approval to first objective concussion diagnostic

4 May 2021 - Oculogica's EyeBOX is the only objective diagnostic cleared by the US FDA and Australia TGA as an ...

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TGA approves key label updates to Buvidal for treatment of opioid dependence

3 May 2021 - Camurus today announced that the Australian regulatory agency, the TGA, has approved key label updates to ...

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Global sarcoma therapy now approved for Australian patients

23 April 2021 - Globally regarded soft tissue sarcoma therapy has been approved by the Therapeutic Goods Administration for Australian patients. ...

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TGA grants provisional determination to GSK for COVID-19 monoclonal antibody treatment - sotrovimab

14 April 2021 - The TGA has granted a provisional determination to GSK in relation to the monoclonal antibody treatment, ...

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Wider storage and transportation conditions for the Pfizer COVID-19 vaccine now approved

8 April 2021 - The Therapeutic Goods Administration has recently approved wider storage and transportation conditions for the Pfizer COVID-19 ...

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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 ...

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Super flu vaccine gets the go-ahead

24 March 2021 - A new type of cell-based influenza vaccine is available this winter that promises to be significantly ...

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TGA approves CSL - Seqirus to manufacture AstraZeneca COVID-19 vaccine in Australia

21 March 2021 - Earlier today, the Therapeutic Goods Administration approved manufacture of the AstraZeneca COVID-19 Vaccine (ChAdOx1-S) in Australia.  ...

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AstraZeneca vaccine allowed by government regulators to be produced in Australia

21 March 2021 - Astra Zeneca vaccines will be produced in Australia from now on after the regulators approved doses being ...

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Approval of updated storage conditions for the Pfizer COVID-19 vaccine

13 March 2021 - The TGA has received and assessed additional data submitted by Pfizer for their COVID-19 vaccine (COMIRNATY - ...

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Australia’s Therapeutic Goods Administration approves Feraccru to treat iron deficiency with or without anaemia in adults

9 March 2021 - Shield Therapeutics notes that Australia’s Therapeutic Goods Administration has registered Feraccru in the Australian Register of ...

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Medicines Australia statement on TGA’s provisional approval of AstraZeneca’s COVID-19 vaccine

16 February 2021 - Medicines Australia welcomes the TGA’s decision granting provisional approval of the AstraZeneca/Oxford University COVID-19 vaccine, marking ...

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TGA provisionally approves AstraZeneca's COVID-19 vaccine

16 February 2021 - The Therapeutic Goods Administration has granted provisional approval to AstraZeneca for its COVID-19 vaccine, making it ...

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TGA approves new formulation of glatiramer acetate

16 February 2021 - The TGA thinks glatiramer acetate (Glatopa) is a new chemical entity. ...

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Precision medicine helping to change the prognosis of a rare subtype of bowel cancer

2 February 2021 - Australians with a specific type of bowel cancer are no longer subject to a ‘one-size fits ...

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