Terminal cancer patients denied new treatments due to slow TGA approval

31 March 2021 - Desperate cancer patients are begging Australia’s drugs regulator to save lives by speeding up approvals and cutting ...

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Building a more robust medicine supply - proposals to help prevent, mitigate and manage medicine shortages

29 March 2021 - The Therapeutic Goods Administration is conducting a public consultation seeking feedback on reforms intended to help ...

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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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Melbourne made COVID-19 vaccine now available

23 March 2021 - The Melbourne manufactured AstraZeneca vaccine is now available for Australians, with the TGA this evening approving ...

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ATAGI statement and clinical guidance on AstraZeneca COVID-19 vaccine following EMA safety review

19 March 2021 - This statement from the Australian Technical Advisory Group on Immunisation updates advice previous provided on 16 March.  ...

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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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AstraZeneca ChAdOx1-S COVID-19

18 March 2021 - The TGA is closely reviewing reports of anaphylaxis after four cases were reported following the AstraZeneca ChAdOx1-S ...

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ATAGI statement in response to European decisions about the AstraZeneca vaccine

16 March 2021 - ATAGI notes the suspension of the AstraZeneca vaccine program in several European countries due to reports ...

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Doctors complain of ‘gag’ over AstraZeneca vaccine

16 March 2021 - High-profile doctors have complained they are being gagged from speaking out about their concerns on the ...

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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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COVID-19 vaccines - safety and effectiveness in older adults

10 March 2021 - Data on real-world use of COVID-19 vaccines approved in Australia provides reassurance about their safety in ...

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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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TGA approves Zolgensma

10 March 2021 - Onasemnogene abeparvovec is a new gene therapy for children with spinal muscular atrophy. ...

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