TGA publishes another AusPAR for Opdivo (nivolumab)

31 March 2020 - First apparent TGA rejection for nivolumab. ...

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International work-sharing initiative - baloxavir marboxil (Xofluza)

5 March 2020 - The Therapeutic Goods Administration (TGA) has approved a new medicine for the treatment of influenza (flu) as ...

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Anti-flu pill can fight illness as soon as symptoms show

4 February 2020 - A new pill that can fight the flu as soon as symptoms strike has been approved ...

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FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukaemia

21 November 2019 - Today, as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, ...

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TGA approves drug to fight ovarian cancer

26 September 2019 - Some women diagnosed with ovarian cancer could have their survival rates significantly increased after the Therapeutic ...

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Provisional approval of lenvatinib in combination with pembrolizumab for the treatment of advanced endometrial carcinoma

18 September 2019 - The Therapeutic Goods Administration has provisionally approved the use of lenvatinib (Lenvima) in combination with pembrolizumab ...

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Alimera announces Iluvien regulatory approval in Australia for the treatment of diabetic macular oedema

5 August 2019 - Specialised Therapeutics, an Australian biopharmaceutical company and Alimera’s distribution partner, to next seek national reimbursement. ...

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'I owe it everything': cancer drug approval win for rare cancers

23 July 2019 - Paul Hazelwood was told there was nothing else doctors could do to treat his rare terminal ...

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International work-sharing Initiative - niraparib (Zejula)

1 July 2019 - The TGA has approved a new drug for the treatment of some ovarian, fallopian tube, or ...

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Newly approved MS drug to offer relief to children

1 May 2019 - A wonder drug to treat children with multiple sclerosis has been approved for use in Australia. ...

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New early breast cancer drug to reduce risk of recurrence or death approved for Australian women

18 March 2019 - Nerlynx (neratinib) now approved by the Therapeutic Goods Administration for Australian women. ...

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Vertex receives approval for Symdeko (tezacaftor/ivacaftor and ivacaftor) in Australia, to treat the underlying cause of cystic fibrosis in people aged 12 and older with certain CFTR gene mutations

12 March 2019 - A new treatment option for patients with two copies of the F508del mutation, the most common mutation ...

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New drug to halve heart patients' cholesterol levels

9 January 2019 - A second drug has been approved for use in Australia for patients with high cholesterol who ...

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Revolutionary' cancer drug using genetically modified cells approved

19 December 2018 - A revolutionary cancer therapy that supercharges a patient's immune cells to hunt and destroy cancer cells ...

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PharmaMar announces the approval of Aplidin in Australia for the treatment of multiple myeloma

11 December 2018 - PharmaMar has licensed Aplidin to its partner, STA, in Australia, New Zealand and several Southeast Asian countries. ...

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