Blog
RSS FeedPosted by Michael Wonder on 05 Jun 2025
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 ...
Posted by Michael Wonder on 22 May 2025
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 ...
Posted by Michael Wonder on 21 May 2025
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. ...
Posted by Michael Wonder on 03 Mar 2025
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 ...
Posted by Michael Wonder on 28 Jan 2025
Apellis receives approval of Syfovre (pegcetacoplan) in Australia for geographic atrophy
27 January 2025 - Apellis Pharmaceuticals announced today that the TGA has approved Syfovre (pegcetacoplan) for the every-other-month treatment of adult ...
Posted by Michael Wonder on 24 Jan 2025
Australia’s TGA approves registration of CSL’s Andembry (garadacimab) for the prevention of recurrent hereditary angioedema attacks
24 January 2025 - This regulatory approval for registration in Australia is the first in the world for Andembry. ...
Posted by Michael Wonder on 19 Jan 2025
Junshi Biosciences announces toripalimab’s approval in Australia
17 January 2025 - Shanghai Junshi Biosciences announced that toripalimab, the anti-PD-1 monoclonal antibody self-developed by the company, has obtained the ...
Posted by Michael Wonder on 18 Oct 2024
Update on regulatory review of lecanemab for early Alzheimer's disease in Australia
17 October 2024 - Eisai announced today that the TGA of Australia issued a public statement about the initial decision ...
Posted by Michael Wonder on 17 Oct 2024
TGA's decision to not register lecanemab (Leqembi)
16 October 2024 - The TGA has made the decision not to register lecanemab (Leqembi) for the treatment of patients ...
Posted by Michael Wonder on 17 Oct 2024
Experts label TGA’s decision to not register Alzheimer’s drug ‘extremely disappointing’
16 October 2024 - A drug that could hold the key to delaying symptoms of devastating Alzheimer’s disease will not be ...
Posted by Michael Wonder on 12 Sep 2024
Diabetes drug Mounjaro approved for obesity treatment by TGA
11 September 2024 - An in-demand diabetes drug that went viral for its weight-loss side effect has been approved to ...
Posted by Michael Wonder on 22 Feb 2024
TGA approves new medication for treatment of endometriosis symptoms
23 February 2024 - Australian drug regulator gives company green light for tablet – although it won’t be subsidised by Pharmaceutical ...
Posted by Michael Wonder on 23 Jan 2024
TGA approves RSV vaccine for use through private prescription for Australians over 60
17 January 2024 - A vaccine for respiratory syncytial virus has been approved by the TGA and will be available through ...
Posted by Michael Wonder on 28 Sep 2023
Akebia announces approval of Vafseo (vadadustat) in Australia
26 September 2023 - Akebia Therapeutics today announced that Australia's TGA has granted approval for Vafseo (vadadustat), an oral hypoxia-inducible ...
Posted by Michael Wonder on 12 Jul 2023
Idefirix (imlifidase) receives provisional approval in Australia as desensitisation treatment in highly sensitised patients prior to kidney transplantation
11 July 2023 - Regulatory milestone marks the first time Idefirix has been approved in kidney transplantation from both living ...