Blog
RSS FeedPosted by Michael Wonder on 26 Jul 2021
TGA international engagement strategy 2021-2025
26 July 2021 - The TGA's International Engagement Strategy 2021-2025 describes how working with our international regulatory counterparts will benefit Australians ...
Posted by Michael Wonder on 25 Jul 2021
COVID-19 demand leads to Australian shortages of rheumatoid arthritis drug
25 July 2021 - Australia is facing shortages of a rheumatoid arthritis drug that has been used to treat COVID-19 ...
Posted by Michael Wonder on 20 Jul 2021
Streamlining proprietary ingredient categories
20 July 2021 - To help make the medicines application process more efficient, the TGA no longer allocates proprietary ingredient ...
Posted by Michael Wonder on 14 Jul 2021
Prescription medicines: applications under evaluation (July 2021 update)
14 July 2021 - The TGA has updated its list of applications for new medicines/vaccines or new uses for existing medicines/vaccines ...
Posted by Michael Wonder on 23 Jun 2021
Fees and charges: summary from 1 July 2021
23 June 2021 - The TGA is required to recover its costs for all activities that fall within the scope of ...
Posted by Michael Wonder on 23 Jun 2021
TGA approves first generic pomalidomide
23 June 2021 - The TGA has approved first generic version of Celgene's Pomalyst. ...
Posted by Michael Wonder on 22 Jun 2021
Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium
22 June 2021 - The TGA is a member of the Access consortium along with Health Canada, Health Sciences Authority of ...
Posted by Michael Wonder on 09 Jun 2021
New Alzheimer’s drug unlikely to be approved in Australia soon, say experts
9 June 2021 - A controversial new drug that has offered hope to Alzheimer’s sufferers by slowing cognitive decline still ...
Posted by Michael Wonder on 24 May 2021
Gilead withdraws submission for Jyseleca
24 May 2021 - Decision should not come as a major surprise given FDA rejection last year. ...
Posted by Michael Wonder on 21 May 2021
TGA evaluating first monoclonal antibody treatment for COVID-19 sotrovimab - GlaxoSmithKline
21 May 2021 - The Therapeutic Goods Administration granted a provisional determination to GlaxoSmithKline in relation to the monoclonal antibody ...
Posted by Michael Wonder on 17 May 2021
TGA weighs over the counter contraceptive pill plan
17 May 2021 - The nation’s medicines regulator is looking at a plan to give Australians more freedom to access ...
Posted by Michael Wonder on 11 May 2021
BMS withdraws application for Opdivo/Yervoy combination
11 May 2021 - Details revealed in new AusPAR. ...
Posted by Michael Wonder on 04 May 2021
TGA approves new treatment for aggressive form of prostate cancer
5 May 2021 - The TGA has registered a new medication to treat a particularly aggressive and advanced type of ...
Posted by Michael Wonder on 03 May 2021
TGA approves key label updates to Buvidal for treatment of opioid dependence
3 May 2021 - Camurus today announced that the Australian regulatory agency, the TGA, has approved key label updates to ...
Posted by Michael Wonder on 26 Apr 2021
Global sarcoma therapy now approved for Australian patients
23 April 2021 - Globally regarded soft tissue sarcoma therapy has been approved by the Therapeutic Goods Administration for Australian patients. ...