Blog
RSS FeedPosted by Michael Wonder on 02 Jul 2019
Schedule of fees and charges
2 July 2019 - 2019-20 fees and charges schedule applies to applications submitted to the TGA on or after 1 July ...
Posted by Michael Wonder on 01 Jul 2019
International work-sharing Initiative - niraparib (Zejula)
1 July 2019 - The TGA has approved a new drug for the treatment of some ovarian, fallopian tube, or ...
Posted by Michael Wonder on 21 Jun 2019
Cost recovery implementation statement
21 June 2019 - The cost recovery implementation statement outlines the TGA's regulatory costs and provides detailed information on TGA's ...
Posted by Michael Wonder on 11 Jun 2019
Ingredient name changes: a medicine ingredient by any other name…
11 June 2019 - Consistent names are important, especially the names we use for important things like medicine ingredients. ...
Posted by Michael Wonder on 23 May 2019
TGA fees and charges: summary from 1 July 2019
23 May 2019 - The TGA is required to recover its costs for all activities that fall within the scope ...
Posted by Michael Wonder on 21 May 2019
South Africa's Aspen sells Australian prescription portfolio to Mylan
20 May 2019 - Aspen Pharmacare has said that Mylan had exercised an option to buy the South African drug ...
Posted by Michael Wonder on 16 May 2019
Sigma Healthcare leadership says it has received no worker reports of medicine mishandling
16 May 2019 - Sigma Healthcare's chief executive Mark Hooper has told investors that the company takes its obligations to ...
Posted by Michael Wonder on 15 May 2019
Sigma Healthcare to face investor questions over claims it mishandled prescription drugs
15 May 2019 - Pharmaceutical supplier Sigma Healthcare will face shareholder questions over claims that it failed to properly handle ...
Posted by Michael Wonder on 08 May 2019
Medicines Australia welcomes ALP R&D investment pledge
8 May 2019 - Medicines Australia welcomes today’s announcement from the Australian Labor Party to reform the Research and Development ...
Posted by Michael Wonder on 01 May 2019
Newly approved MS drug to offer relief to children
1 May 2019 - A wonder drug to treat children with multiple sclerosis has been approved for use in Australia. ...
Posted 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 16 Apr 2019
Labor to fast-track leukaemia drug trials
17 April 2019 - Patients with deadly blood cancers will get faster access to potentially life-saving drug trials if Labor ...
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 ...