Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 29 Jun 2023
Lymphoma therapy now approved for Australian patients with diffuse large B-cell lymphoma
28 June 2023 - Recent five-year follow-up data from Phase 2 L-MIND investigation showed patients treated with Minjuvi had prolonged, ...
Posted by Michael Wonder on 06 Jun 2023
‘Future of cancer treatment’ has just been approved
6 June 2023 - Australian scientists pioneering a new type of therapy, which re-engineers a patient’s own T-cells, could result in ...
Posted by Michael Wonder on 27 Apr 2023
Moderna’s COVID-19 vaccine Spikevax receives approval for full registration
24 April 2023 - On 21 April, the TGA approved Moderna Australia’s application to transition its COVID-19 vaccine, Spikevax (elasomeran), ...
Posted by Michael Wonder on 25 Mar 2023
Lapse of provisional registration for Tecentriq (atezolizumab) for the treatment of locally advanced or metastatic triple negative breast cancer
22 March 2023 - On 22 March 2023, the provisional registration of Tecentriq (atezolizumab) for the treatment of mTNBC will ...
Posted by Michael Wonder on 26 Jan 2023
Evolus receives regulatory approval for Nuceiva in Australia
23 January 2023 - Australia among the largest countries in the world for aesthetic neurotoxins. ...
Posted by Michael Wonder on 23 Jan 2023
TGA grants provisional approval to Pfizer’s COVID-19 bivalent (Comirnaty Original/Omicron BA.4-5 COVID-19 vaccine) booster dose vaccine
23 January 2023 - On 20 January 2023, the TGA granted provisional approval to Pfizer’s bivalent COVID-19 vaccine: tozinameran and famtozinameran ...
Posted by Michael Wonder on 28 Nov 2022
Croma Australia, a subsidiary of Hugel Aesthetics, receives TGA approval in Australia for Letybo (letibotulinumtoxinA) for the treatment of glabellar lines
28 November 2022 - Approval is supported by positive results from three completed Phase 3 trials that enrolled more than 1000 ...