Blog
RSS FeedPosted 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. ...
Posted by Michael Wonder on 14 Apr 2021
TGA grants provisional determination to GSK for COVID-19 monoclonal antibody treatment - sotrovimab
14 April 2021 - The TGA has granted a provisional determination to GSK in relation to the monoclonal antibody treatment, ...
Posted by Michael Wonder on 30 Mar 2021
Terminal cancer patients denied new treatments due to slow TGA approval
31 March 2021 - Desperate cancer patients are begging Australia’s drugs regulator to save lives by speeding up approvals and cutting ...
Posted by Michael Wonder on 29 Mar 2021
Building a more robust medicine supply - proposals to help prevent, mitigate and manage medicine shortages
29 March 2021 - The Therapeutic Goods Administration is conducting a public consultation seeking feedback on reforms intended to help ...
Posted by Michael Wonder on 24 Mar 2021
Vertex receives Australian TGA approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to treat people with cystic fibrosis ages 12 years and older who have at least one F508del mutation
24 March 2021 - With this approval approximately 750 people living with cystic fibrosis in Australia will be newly eligible for ...