Blog
RSS FeedPosted 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 21 Jan 2025
Drug shortage crisis demands intervention, AMA warns, as patients struggle to secure medicines
20 January 2025 - There are more than 400 medicine shortages, and the country’s leading medical group blames it on ‘ad ...
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 15 Dec 2024
ARS Pharmaceuticals announces filings for approval of neffy in China, Japan and Australia
12 December 2024 - Licensing partners in key Asia Pacific countries have filed for approval of neffy (epinephrine nasal spray) ...
Posted by Michael Wonder on 13 Nov 2024
How the Morrison Government passed over an Australian company for a US pharmaceutical giant
13 November 2024 - Australia’s audit office will probe the Morrison Government’s $2 billion deal with US pharmaceutical giant Moderna ...
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 03 Oct 2024
KalVista announces the submission of additional marketing authorisation applications for sebetralstat for the oral on-demand treatment of hereditary angioedema
30 September 2024 - If approved, sebetralstat will be the first, oral on-demand treatment for HAE. ...
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 28 Aug 2024
Mark Butler secures 22 million IV fluid bags amid major shortage
27 August 2024 - The federal government has secured 22 million bags of IV fluids amid a major supply shortage ...
Posted by Michael Wonder on 21 Aug 2024
Dying patients up for $4,000 painkillers in drug supply crisis
21 August 2024 - Dying patients may have to pay more than $4,000 for a box of imported pain-killing tablets ...
Posted by Michael Wonder on 17 Aug 2024
Intravenous scandal escalates: the excuses are fluid
15 August 2024 - A shortage of intravenous IV fluid bags that is causing chaos in Australian hospitals is being ...