Blog
RSS FeedPosted by Michael Wonder on 06 May 2026
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 ...
Posted by Michael Wonder on 04 May 2026
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 ...
Posted by Michael Wonder on 02 May 2026
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 ...
Posted by Michael Wonder on 16 Feb 2026
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 ...
Posted by Michael Wonder on 14 Jan 2026
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). ...
Posted by Michael Wonder on 25 Sep 2025
‘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 ...
Posted by Michael Wonder on 24 Sep 2025
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 ...
Posted by Michael Wonder on 20 Sep 2025
A new era of dementia treatment is coming. We are not ready.
19 September 2025 - Inequality in accessing new drugs, the high cost of treatment, and underprepared hospital systems: these obstacles to ...
Posted by Michael Wonder on 20 Aug 2025
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. ...
Posted 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. ...