Blog
RSS FeedPosted by Michael Wonder on 21 Sep 2018
New indication for Opdivo (nivolumab) after TGA approval for hepatocellular carcinoma
21 September 2018 - Opdivo now approved in Australia for eleven indications across seven cancer areas in under three years. ...
Posted by Michael Wonder on 18 Sep 2018
Australia unveils strategy for engaging with foreign regulators
17 September 2018 - Australia’s TGA revealed a three-part plan on Monday to operationalise its strategy on engaging international regulators ...
Posted by Michael Wonder on 18 Sep 2018
TGA international engagement strategy: operations plan 2018-19
17 September 2018 - To support Australian regulatory decisions the TGA considers international reports and evaluations, monitor early warnings and ...
Posted by Michael Wonder on 11 Sep 2018
New law to protect patients against medicine shortages
11 September 2018 - The supply of critical and life-saving medicine to Australian patients will now be protected with the Parliament ...
Posted by Michael Wonder on 03 Sep 2018
How robots and ‘smart-bomb’ drugs saved dying baby Ellie
2 September 2018 - Just a year ago, Ellie Caterjian could barely breathe because the 11-month-old had a tumour the ...
Posted by Michael Wonder on 03 Sep 2018
TGA Facebook has officially launched
3 September 2018 - Today we celebrate the official launch of the Therapeutic Goods Administration Facebook page. ...
Posted by Michael Wonder on 22 Aug 2018
New drug able to overcome migraines available in Australia for millions suffering in silence
22 August 2018 - A new monthly injection that promises to eliminate or cut migraines will be available to desperate ...
Posted by Michael Wonder on 03 Aug 2018
Celltrion’s biosimilar Herzuma approved in Australia
2 August 2018 - Korean biopharmaceutical firm Celltrion said on 2 August that its breast cancer biosimilar has been approved ...
Posted by Michael Wonder on 01 Aug 2018
Fast-tracking of new drugs: getting the balance right
1 August 2018 - In Australia, like the rest of the world, patients and their doctors have a growing desire ...
Posted by Michael Wonder on 30 Jul 2018
Special Access Scheme online system
30 July 2018 - On Monday 30 July 2018, an online system was introduced to enable the electronic submission of SAS ...
Posted by Michael Wonder on 20 Jul 2018
Sanofi withdraws TGA submission for Kevzara
20 July 2018 - Outcome only made public after the publication of an AusPAR. ...
Posted by Michael Wonder on 18 Jul 2018
$50 million to provide life-saving support to cancer patients
18 July 2018 - The Australian Government will provide $50 million to support some of Australia’s sickest patients, battling the most ...
Posted by Michael Wonder on 17 Jul 2018
Federal Government to announce $50 million custom cancer drug trial
17 July 2018 - Almost 600 Queenslanders will have their cancer’s DNA tested to identify the drugs that will keep ...
Posted by Michael Wonder on 13 Jul 2018
TGA calls on drug company to improve warnings over children's asthma drug after suicide
13 July 2018 - The TGA has called on manufacturers of the asthma medication Singulair to add warnings inside the ...
Posted by Michael Wonder on 12 Jul 2018
Two boys, one horrific disease, different wonder drug funding
12 July 2018 - A young boy dying of a rare and horrifying genetic disease faces losing access to a ...