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RSS FeedPosted 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 ...
Posted by Michael Wonder on 25 Nov 2022
Hugel's 'Letybo' first in Korea to obtain marketing approval from Australia
24 November 2022 - Obtained marketing approval on the 23rd (local time) from the TGA of Australia for the indication of ...
Posted by Michael Wonder on 17 Nov 2022
Amarin announces Vazkepa (icosapent ethyl) approved by the TGA in Australia
15 November 2022 - Marks fifth regulatory approval for Vascepa/Vazkepa franchise in key international markets in 2022. ...
Posted by Michael Wonder on 16 Nov 2022
TGA grants provisional determination to Pfizer’s COVID-19 bivalent (Comirnaty Bivalent Omicron BA.4/BA.5) booster dose vaccine
16 November 2022 - On 15 November 2022, the TGA granted a provisional determination to Pfizer’s bivalent COVID-19 vaccine candidate: tozinameran ...
Posted by Michael Wonder on 28 Oct 2022
TGA provisionally approves Pfizer bivalent COVID-19 vaccine for use as a booster dose in adults
28 October 2022 - On 27 October 2022, the TGA provisionally approved Pfizer’s bivalent COVID-19 vaccine, tozinameran and riltozinameran (COMIRNATY Original/Omicron ...