Blog
RSS FeedPosted by Michael Wonder on 06 Jul 2022
TGA grants provisional determinations to Pfizer for COVID-19 vaccines to target Omicron variant
6 July 2022 - On 5 July 2022, the TGA granted two provisional determinations to Pfizer in relation to COVID-19 ...
Posted by Michael Wonder on 05 Jul 2022
ATAGI update following weekly COVID-19 meeting (29 June 2022)
5 July 2022 - An update from the Australian Technical Advisory Group on Immunisation (ATAGI) following their weekly meeting on 29 ...
Posted by Michael Wonder on 04 Jul 2022
Report on 'Cell, Gene and Tissue Regulatory Framework in Australia: Stakeholder Perspectives' - TGA response
4 July 2022 - n November 2021 the TGA commissioned MTP Connect to conduct a stakeholder review of the regulatory ...
Posted by Michael Wonder on 01 Jul 2022
COVID-19 vaccine safety report (30 June 2022)
30 June 2022 - The Australian Government has decided the COVID-19 vaccine safety report will now be published fortnightly instead of ...
Posted by Michael Wonder on 30 Jun 2022
Review into COVID-19 vaccine and treatment purchases
30 June 2022 - The Australian Government is undertaking an independent review of Australia’s vaccine and treatment procurements, led by former ...
Posted by Michael Wonder on 30 Jun 2022
Provisional determination granted to Pfizer in relation to COVID 19 vaccine (Comirnaty) - for use in individuals 6 months up to 5 years
30 June 2022 - On 28 June 2022, the TGA granted a provisional determination to Pfizer Australia in relation to ...
Posted by Michael Wonder on 28 Jun 2022
Fees and charges: summary from 1 July 2022
27 June 2022 - The TGA has updated its summary of fees and charges effective 1 July 2022. ...
Posted by Michael Wonder on 23 Jun 2022
COVID-19 vaccine weekly safety report (23 June 2022)
23 June 2022 - To 19 June 2022, the TGA has received 581 reports which have been assessed as likely to ...
Posted by Michael Wonder on 19 Jun 2022
IP waiver for COVID vaccines is a threat to future innovation
20 June 2022 - The decision to waive intellectual property protections for COVID-19 vaccines is fundamentally flawed and will have ...
Posted by Michael Wonder on 16 Jun 2022
COVID-19 vaccine weekly safety report (16 June 2022)
16 June 2022 - To 12 June 2022, the TGA has received 584 reports which have been assessed as likely to ...
Posted by Michael Wonder on 15 Jun 2022
TGA approves Vyxeos
15 June 2022 - This marks the first TGA approval for Jazz Pharmaceuticals. ...
Posted by Michael Wonder on 15 Jun 2022
TGA approval of Kimmtrak
15 June 2022 - Tebentafusp is a bi-specific fusion protein. ...
Posted by Michael Wonder on 14 Jun 2022
Novavax COVID-19 vaccine Nuvaxovid provisionally registered in Australia as a booster in individuals aged 18 and over
13 June 2022 - In Australia, Nuvaxovid is the first protein-based COVID-19 vaccine registered for use as a booster regardless ...
Posted by Michael Wonder on 09 Jun 2022
COVID-19 vaccine weekly safety report (9 June 2022)
9 June 2022 - To 5 June 2022, the TGA has received 577 reports which have been assessed as likely to ...
Posted by Michael Wonder on 08 Jun 2022
The UK MHRA, Australian TGA and Health Canada approve Kimmtrak (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma
8 June 2022 - Kimmtrak demonstrated statistically and clinically meaningful overall survival benefit, hazard ratio of 0.51, with median overall survival ...