Roche’s Ocrevus (ocrelizumab) approved for relapsing and primary progressive multiple sclerosis in Australia

17 July 2017 - Second approval after the US for Ocrevus as the first and only approved treatment for people with ...

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Generic and biosimilar prescription medicines, 2016

13 June 2017 -The generic and biosimilar prescription medicines: TGA annual summary 2016 publication provides details of all generic and ...

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MSD plans 2017 launch of Renflexis (infliximab) in Australia

1 May 2017 - Latest MSD biosimilar secures TGA approval. ...

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Therapeutic Goods Administration approves Afstyla - CSL Behring's novel recombinant haemophilia A treatment

19 April 2017 - In clinical trials, patients undergoing prophylaxis with Afstyla experienced a median annualised spontaneous bleeding rate of ...

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Submissions received and TGA response: orphan drug program

18 April 2017 - The TGA would like to thank respondents who provided submissions in response to the October 2016 ...

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TGA approval timelines for new cancer medicines

13 February 2017 - The publication of submission dates in the TGA's Annual Report for 2016 enables more insightful analysis ...

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Diabetes drug that cuts sugar will also reduce heart problems

2 February 2017 - Diabetes will no longer be a death sentence for many sufferers, with a drug often prescribed ...

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Australian approval for drug that 'melts' leukaemia

10 January 2017 - A new anti-cancer drug with the power to ‘melt away’ certain advanced forms of chronic lymphocytic ...

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TGA approves new lung cancer drug osimertinib for patients dealt cruel double blow

23 December 2016 - Elly Calabia doesn't talk about survival rates and life expectancy with her oncologist.  ...

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TGA approves new uses for Janssen's Imbruvica

20 December 2016 - The TGA has approved the use of ibrutinib for first-line use in patients with chronic lymphocytic ...

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Antizol approved by TGA

5 December 2016 - The TGA has approved a new medicine from AFT Pharmaceuticals. ...

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Nocdurna approved by TGA

5 December 2016 - The TGA has approved a new indication for Ferring's desmopressin acetate. ...

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TGA approves AbbVie's Technivie

5 December 2016 - The TGA has approved another AbbVie combination product for use by patients with chronic hepatitis C ...

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TGA approves extended use of Harvoni

23 November 2016 - The TGÅ has approved the use of Harvoni in additional genotypes. ...

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Belsomra finally approved by TGA

23 November 2016 - The TGA has approved MSD's orexin receptor antagonist. ...

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