iHealthScreen announces TGA approval for iPredict automated AI system for early diagnosis of diabetic retinopathy, age-related macular degeneration and glaucoma suspect

19 April 2022 - iHealthScreen is the first company in the USA to receive a CE certification, Australian Health approval, and ...

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TGA approves Lumakras

13 April 2022 - Sotorasib is a Kirsten rat sarcoma (KRAS) G12C inhibitor, which covalently and irreversibly binds to the unique ...

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TGA approves new medicine for patients with SLE

12 April 2022 - Anifrolumab is a human immunoglobulin G1 kappa monoclonal antibody that binds to subunit 1 of the type ...

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TGA approved Yuflyma

8 April 2022 - The TGA has approved yet another adalimumab biosimilar. ...

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TGA provisionally approves Pfizer’s COVID-19 vaccine (Comirnaty), for use as a booster for individual aged 12–15 years old

8 April 2022 - The TGA has provisionally approved the Pfizer Australia Pty Ltd COVID-19 vaccine, Comirnaty, for use as a ...

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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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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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Hope for quadriplegics as ‘miracle treatment’ gets green light from regulator

21 March 2022 - In a major step forward for treating victims of paralysis, Australian regenerative medicine company Orthocell has ...

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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 provisional determination for Biocelect for COVID-19 vaccine Nuvaxovid

10 March 2022 - The TGA has granted a second provisional determination to Biocelect (on behalf of Novavax) in relation ...

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TGA approves Sogroya

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

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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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