Blog
RSS FeedPosted by Michael Wonder on 25 Apr 2019
Aytu BioScience announces submission of ZolpiMist for approval to Australian TGA
24 April 2019 - Australian TGA approval decision expected in early 2020. ...
Posted by Michael Wonder on 09 Apr 2019
International work-sharing initiative - abemaciclib (Verzenio)
9 April 2019 - Abemaciclib (Verzenio) is the second medicine to be registered on the Australian Register of Therapeutic Goods ...
Posted by Michael Wonder on 18 Mar 2019
New early breast cancer drug to reduce risk of recurrence or death approved for Australian women
18 March 2019 - Nerlynx (neratinib) now approved by the Therapeutic Goods Administration for Australian women. ...
Posted by Michael Wonder on 12 Mar 2019
Vertex receives approval for Symdeko (tezacaftor/ivacaftor and ivacaftor) in Australia, to treat the underlying cause of cystic fibrosis in people aged 12 and older with certain CFTR gene mutations
12 March 2019 - A new treatment option for patients with two copies of the F508del mutation, the most common mutation ...
Posted by Michael Wonder on 15 Feb 2019
Whether the TGA should publish that a prescription medicine is under evaluation
15 February 2019 - The TGA is seeking comments from interested parties on whether or not the TGA should in future ...
Posted by Michael Wonder on 16 Jan 2019
Sweet smell of success for patients taking the sugar pill
15 January 2019 - A placebo is anything that seems to offer a real medical treatment, but doesn’t. It could ...
Posted by Michael Wonder on 09 Jan 2019
New drug to halve heart patients' cholesterol levels
9 January 2019 - A second drug has been approved for use in Australia for patients with high cholesterol who ...
Posted by Michael Wonder on 12 Dec 2018
PharmaMar announces the approval of Aplidin in Australia for the treatment of multiple myeloma
11 December 2018 - PharmaMar has licensed Aplidin to its partner, STA, in Australia, New Zealand and several Southeast Asian countries. ...
Posted by Michael Wonder on 03 Dec 2018
Australia's first telehealth cancer drug trial
3 December 2018 - A partnership between north Queensland hospitals is bringing potentially life-saving cancer drug trials to rural patients. ...
Posted by Michael Wonder on 03 Dec 2018
Zambon announces approval and ARTG listing of safinamide in Australia for treatment of patients with Parkinson’s disease
30 November 2018 - Further regulatory submissions on-going with authorities worldwide. ...
Posted by Michael Wonder on 03 Nov 2018
It feels dodgy': parents bypass TGA to buy sleep drug from overseas
4 November 2018 - Consumers are circumventing Australian regulations to buy cheap melatonin from overseas where it can be obtained ...
Posted by Michael Wonder on 02 Nov 2018
Comparable overseas reports pathway - first registration decision
2 November 2018 - Cabozantinib (Cabometyx) is the first medicine to be registered on the Australian Register of Therapeutic Goods ...
Posted by Michael Wonder on 01 Nov 2018
Update on the Australia-Canada Mutual Recognition Agreement
1 November 2018 - Common Statement regarding inclusion of Active Pharmaceutical Ingredient in Australia-Canada Mutual Recognition Agreement (as of November 1, ...
Posted by Michael Wonder on 12 Oct 2018
TGA fees and charges: summary from 1 July 2018
12 October 2018 - The TGA is required to recover its costs for all activities that fall within the scope of ...
Posted by Michael Wonder on 09 Oct 2018
WA family forced to pay $40k a year for son's medicinal cannabis
9 October 2018 - When Perth mother Lisa Johnson gave the first drops of cannabis oil to her severely disabled ...