Blog
RSS FeedPosted by Michael Wonder on 22 Jan 2018
Registration of new chemical entities in Australia
22 January 2018 - New year leads to improved transparency on regulatory dossier timelines; submission dates yet to be disclosed. ...
Posted by Michael Wonder on 08 Dec 2017
Merck receives approval (updated registration) for Mavenclad (cladribine tablets) in Australia
7 December 2017 - First treatment in relapsing-remitting multiple sclerosis to show sustained clinical efficacy for up to 4 years with ...
Posted by Michael Wonder on 25 Oct 2017
VivaGel BV granted marketing approval in Australia
25 October 2017 - Starpharma today announced it has received Australian marketing approval from the TGA for VivaGel BV, which ...
Posted by Michael Wonder on 17 Oct 2017
Anika announces regulatory approval for Monovisc in Australia for the treatment of pain associated with osteoarthritis of all synovial joints
16 October 2017 - Anika Therapeutics today announced that regulatory authorities in Australia granted approval to Monovisc, Anika's single injection ...
Posted by Michael Wonder on 12 Sep 2017
Annual performance statistics report: July 2016 to June 2017
12 September 2017 - Since the 2015-16 report, the number of submissions received across some Category 1 application types varied significantly. ...
Posted by Michael Wonder on 11 Sep 2017
Meningococcal vaccine approved for infants
11 September 2017 - A vaccine that protects very young children against four strains of meningococcal has been approved by the ...
Posted by Michael Wonder on 01 Sep 2017
Provisional approval pathway for prescription medicines
1 September 2017 - The TGA would like to thank respondents who provided submissions in response to the March 2017 ...
Posted by Michael Wonder on 16 Aug 2017
Amicus Therapeutics announces approval for Galafold (migalastat) for treatment of Fabry disease in Australia
15 August 2017 - First Amicus medicine and first oral precision medicine for Fabry disease in Australia. ...
Posted by Michael Wonder on 18 Jul 2017
Roche’s Ocrevus (ocrelizumab) approved for relapsing and primary progressive multiple sclerosis in Australia
17 July 2017 - Second approval after the US for Ocrevus as the first and only approved treatment for people with ...
Posted by Michael Wonder on 13 Jun 2017
Generic and biosimilar prescription medicines, 2016
13 June 2017 -The generic and biosimilar prescription medicines: TGA annual summary 2016 publication provides details of all generic and ...
Posted by Michael Wonder on 02 May 2017
MSD plans 2017 launch of Renflexis (infliximab) in Australia
1 May 2017 - Latest MSD biosimilar secures TGA approval. ...
Posted by Michael Wonder on 20 Apr 2017
Therapeutic Goods Administration approves Afstyla - CSL Behring's novel recombinant haemophilia A treatment
19 April 2017 - In clinical trials, patients undergoing prophylaxis with Afstyla experienced a median annualised spontaneous bleeding rate of ...
Posted by Michael Wonder on 18 Apr 2017
Submissions received and TGA response: orphan drug program
18 April 2017 - The TGA would like to thank respondents who provided submissions in response to the October 2016 ...
Posted by Michael Wonder on 12 Feb 2017
TGA approval timelines for new cancer medicines
13 February 2017 - The publication of submission dates in the TGA's Annual Report for 2016 enables more insightful analysis ...
Posted by Michael Wonder on 01 Feb 2017
Diabetes drug that cuts sugar will also reduce heart problems
2 February 2017 - Diabetes will no longer be a death sentence for many sufferers, with a drug often prescribed ...