TGA receives application for an increased dose of GlaxoSmithKline’s COVID-19 treatment sotrovimab (Xevudy) for the BA.2 omicron sublineage

7 April 2022 - The TGA has received an application from GSK for a higher (1,000 mg) dose of its ...

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TGA approves yet another new medicine for patients with psoriasis

7 April 2022 - Bimekizumab is a humanised immunoglobulin G1 kappa monoclonal antibody. It has two identical antigen binding regions that ...

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Locally made medicines

4 April 2022 - The Morrison Government is supporting new local jobs in Australia’s innovative medical sector and investing to secure ...

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Here comes yet another new medicine for patients with MS

4 April 2022 - The TGA has approved Vumerity (diroximel fumarate). ...

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TGA approves new medicine for patients with multiple sclerosis

24 March 2022 - Ponesimod is a sphingosine 1 phosphate receptor 1 modulator. ...

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Prescription medicines: new or extended uses, or new combinations of registered medicines (February 2022)

22 March 2022 - The TGA approved a new indication for 7 medicines and one vaccine in February. ...

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Prescription medicines: applications under evaluation (March 2022)

22 March 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...

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Australian cancer patients to get improved access to clinical trials

17 March 2022 - Australian cancer patients will get improved access to local clinical trials through a new public-private partnership ...

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Backing life-saving local cancer drug development

17 March 2022 - Joint media release with the Minister for Health and Aged Care the Hon Greg Hunt MP. ...

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Single dose Kozenis (tafenoquine) approved for children with Plasmodium vivax malaria by Australian Therapeutic Goods Administration

14 March 2022 - Novel paediatric relapse prevention treatment marks a major contribution towards malaria elimination efforts. ...

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Antengene announces Xpovio approved by the TGA in Australia for the treatment of relapsed and/or refractory multiple myeloma and triple class-refractory multiple myeloma

10 March 2022 - Xpovio is the first of a new class of SINE (selective inhibitor of nuclear export) medicines. ...

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TGA approves Sogroya

8 March 2022 - Somapacitan is a long‑acting recombinant human growth hormone derivative. ...

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Australian COVID nasal spray not on shop shelves amid TGA dispute

4 March 2022 - Melbourne start-up Starpharma is at loggerheads with the medicines regulator over the approvals process for its ...

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Jemperli approved by the TGA

2 March 2022 - Dostarlimab is an anti-programmed cell death protein 1 immunoglobulin G4 humanised monoclonal antibody, derived from a stable ...

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Prescription medicines: applications under evaluation (February 2022)

25 February 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...

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