Norgine welcomes TGA registration in Australia of Pedmarqsi (sodium thiosulphate anhydrous) for the prevention of cisplatin-induced hearing loss in children

6 May 2026 - Norgine is pleased to announce that Pedmarqsi (sodium thiosulphate anhydrous) has been registered by the Australian TGA ...

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New first in class therapy for chronic graft versus host disease approved in Australia

3 May 2026 -  Specialised Therapeutics is pleased to announce that Niktimvo (axatilimab) has been approved for use in Australia ...

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Arrowhead Pharmaceuticals receives TGA approval of Redemplo (plozasiran) in Australia, expanding global access for patients with familial chylomicronaemia syndrome

1 May 2026 - The approval in Australia is based on positive results from the Phase 3 PALISADE study where ...

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neffy, adrenaline nasal spray, now approved to treat anaphylaxis in Australia

16 February 2026 - CSL Seqirus has today announced that neffy adrenaline (epinephrine) nasal spray is now available and has been ...

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TGA approves registration of lenacapavir for pre-exposure prophylaxis for HIV (Yeytuo)

9 January 2026 - On 17 December 2025, the TGA made the decision to approve the registration of lenacapavir (Yeytuo). ...

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‘A brand new era in Alzheimer’s therapy’: drug cleared by regulator

24 September 2025 - Australia’s drug regulator has approved the registration of an ­amyloid-reducing therapy for Alzheimer’s disease after twice ...

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Leqembi (lecanemab) approved for the treatment of Alzheimer’s disease in Australia

24 September 2025 - Eisai and Biogen announced today that the TGA of Australia has approved the humanised anti-soluble aggregated ...

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First of its kind Ozempic listing for kidney disease

19 August 2025 - Regulators have approved Ozempic’s use for kidney disease treatment, opening the door to new combination therapies. ...

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TGA approves weight loss drug to treat sleep disorder

4 June 2025 - The country’s medicines regulator has approved the use of a GLP-1 weight-loss drug to treat people ...

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New Alzheimer’s drug available today for Australian patients

22 May 2025 - A new drug to treat the early stages of Alzheimer’s disease has been approved for use ...

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Lilly's Kisunla (donanemab) receives marketing authorisation in Australia for the treatment of early symptomatic Alzheimer's disease

21 May 2025 - The authorisation in Australia is for adult patients who are Apolipoprotein E-ε4 heterozygotes or non-carriers. ...

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TGA decides not to register lecanemab in Australia

3 March 2025 - BioArctic's partner Eisai announced today that the TGA has declined the approval of lecanemab as a treatment ...

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NASWSI and Project Orbis - are they essentially the same?

7 September 2022 - We compare and contrast the two initiatives to bring new medicines to the market faster. ...

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MS Health push for nurses to hand out abortion pills

27 July 2022 - Nurses and midwives would prescribe medical abortion pills under a push by the company that imports ...

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Terminal cancer patients denied new treatments due to slow TGA approval

31 March 2021 - Desperate cancer patients are begging Australia’s drugs regulator to save lives by speeding up approvals and cutting ...

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