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RSS FeedPosted by Michael Wonder on 23 Jan 2023
TGA commences evaluation of Moderna COVID-19 vaccine (Spikevax) for potential transition to full registration
20 January 2023 - The TGA has commenced evaluation of an application from Moderna to transition its COVID-19 vaccine, Spikevax, ...
Posted by Michael Wonder on 16 Jan 2023
The game-changing plan to cut barriers to medical abortion
16 January 2023 - A push is under way to make medical abortion more accessible across Australia by cutting down ...
Posted by Michael Wonder on 13 Jan 2023
COVID-19 vaccine safety report (12 January 2023)
12 January 2023 - Since the beginning of the vaccine rollout to 8 January 2023, almost 65 million doses of COVID-19 ...
Posted by Michael Wonder on 22 Dec 2022
COVID-19 vaccine safety report (22 December 2022)
22 December 2022 - This is an abbreviated version of the COVID-19 vaccine safety report. ...
Posted by Michael Wonder on 20 Dec 2022
COVID-19 vaccine safety report (15 December 2022)
15 December 2022 - To 11 December 2022, the TGA has received 706 reports which have been assessed as likely to ...
Posted by Michael Wonder on 03 Dec 2022
COVID-19 vaccine safety report (1 December 2022)
1 December 2022 - To 27 November 2022, the TGA has received 709 reports which have been assessed as likely to ...
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 28 Nov 2022
An open letter to doctors from the TGA
28 November 2022 - The TGA welcomes feedback and is committed to continuously improving processes and communications. ...
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 19 Nov 2022
COVID-19 vaccine safety report (17 November 2022)
17 November 2022 - To 13 November 2022, the TGA has received 706 reports which have been assessed as likely to ...
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 15 Nov 2022
ATAGI recommendations on use of the Pfizer COVID-19 vaccine for children aged 6 months to 4 years
15 November 2022 - On 29 September 2022, the TGA provisionally approved Comirnaty (Pfizer) COVID-19 vaccine for use in children ...
Posted by Michael Wonder on 15 Nov 2022
ATAGI recommendations on use of the Pfizer bivalent (Original/Omicron BA.1) COVID-19 vaccine
15 November 2022 - On 27 October 2022, the TGA provisionally approved the Pfizer (Comirnaty) Bivalent Original/Omicron BA.1 vaccine (subsequently referred ...
Posted by Michael Wonder on 15 Nov 2022
ATAGI update on boosters following COVID-19 meeting on 11 November 2022
15 November 2022 - An update from the Australian Technical Advisory Group on Immunisation (ATAGI) following their meeting on 11 November ...