Blog
RSS FeedPosted by Michael Wonder on 01 May 2018
Opdivo (nivolumab) is the first and only anti-PD-1 therapy approved by TGA for adjuvant treatment of melanoma
30 April 2018 - Opdivo now approved in Australia for nine indications across six cancer areas in under three years. ...
Posted by Michael Wonder on 16 Apr 2018
Provisional approval pathway - first determination decision
16 April 2018 - Olaratumab (Lartruvo) is the first medicine to be granted a provisional approval determination under the new ...
Posted by Michael Wonder on 06 Apr 2018
MorphoSys announces approvals for Tremfya (guselkumab) for the treatment of moderate-to-severe plaque psoriasis in Brazil and Australia
5 April 2018 - MorphoSys announced today that country subsidiaries of its licensee Janssen reported that Tremfya (guselkumab) has been ...
Posted by Michael Wonder on 28 Mar 2018
Mylan and Biocon receive approvals from the European Commission and TGA Australia for Semglee, biosimilar insulin glargine
27 March 2018 - Mylan and Biocon today announced that their co-developed biosimilar insulin glargine Semglee has received marketing authorisation ...
Posted by Michael Wonder on 13 Feb 2018
All TGA approvals for prescription medicines in 2017 met the statutory timeframe of 255 working days
9 February 2018 - A recent media report suggesting that half of TGA approvals for prescription medicines in 2017 exceeded ...
Posted by Michael Wonder on 07 Feb 2018
Priority review pathway - first registration decision
6 February 2018 - Alectinib hydrochloride (Alecensa) is the first medicine to be registered on the Australian Register of Therapeutic ...
Posted by Michael Wonder on 01 Feb 2018
TGA approves first Humira biosimilar
1 February 2018 - Hadlima was registered by the TGA on 24 January 2018. ...
Posted 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. ...