BeiGene announces first regulatory approval in Australia for Brukinsa (zanubrutinib) for treatment of patients with Waldenström’s macroglobulinaemia

7 October 2021 - Represents Brukinsa’s second recent approval in the Asia-Pacific region, following October 1 approval in Singapore for treatment ...

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Joint statement: supply allocations of intravenous tocilizumab (Actemra) during serious shortage

7 October 2021 - Roche, the sponsor of tocilizumab (Actemra), notified the TGA of shortages of multiple presentations of tocilizumab ...

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Australian Government buys 300,000 doses of Merck COVID-19 treatment drug molnupiravir that has not yet been approved

5 October 2021 - While Australia is still trying to reach its COVID-19 vaccination targets, treatment options for the virus ...

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Australia secures additional supplies of sotrovimab

4 October 2021 - The Australian Government has increased supplies of the promising COVID-19 treatment sotrovimab with over 15,000 additional doses ...

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TGA grants provisional determination to Pfizer's COVID-19 treatment PF-07321332 and ritonavir

5 October 2021 - On 1 October 2021, the TGA granted provisional determination to Pfizer in relation to a new ...

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Medicines industry continues to protect Australians from medicine shortages

30 September 2021 - ACCC extends approval for ongoing collaboration ...

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Data protection scheme for assessed listed medicines

29 September 2021 - The TGA has implemented a data protection scheme for assessed listed medicines.  ...

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TGA grants provisional determination to Roche COVID-19 treatment tocilizumab (Actemra)

28 September 2021 - On 27 September 2021, the TGA granted provisional determination to Roche in relation to the COVID-19 ...

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Australia secures supply of drug that treats arthritis and Covid

25 September 2021 - Health Minister Greg Hunt has secured an extra supply of a rheumatoid arthritis drug to treat critically ...

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TGA approves Leqvio

22 September 2021 - Inclisiran is a cholesterol lowering double-stranded small interfering ribonucleic acid. ...

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Final report on the Australian Government response to the recommendations of the Senate Community Affairs References Committee Report

15 September 2021 - The Government acknowledges the efforts and actions detailed in this progress report to implement the Senate ...

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Trodelvy approved by the TGA

14 September 2021 - Sacituzumab govitecan is a new treatment option for adult patients with unresectable locally advanced or metastatic triple negative ...

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New therapy to treat advanced small cell lung cancer approved for Australian patients

14 September 2021 - Zepzelca approval granted under a provisional regulatory pathway. ...

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Joint statement of support for an Australian Patent Box

13 September 2021 - Australia’s health innovators support the introduction of a Patent Box, and we welcome this initiative by the ...

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Trodelvy approved following heroic efforts of breast cancer sufferer Alison Day

12 September 2021 - A dying woman’s selfless campaign will give Australian women battling a rare aggressive form of breast cancer ...

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