Blog
RSS FeedPosted 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 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 24 Sep 2018
Sun Pharma announces Australian TGA approval of Ilumya (tildrakizumab) for treatment of moderate-to-severe plaque psoriasis
21 September 2018 - Sun Pharma today announced that it has received the Australian TGA approval for its speciality product, Ilumya ...
Posted 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 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 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 12 Jul 2018
Opdivo + Yervoy: first combination immunotherapy for advanced renal cell carcinoma (kidney cancer) receives TGA approval
11 July 2018 - Opdivo now approved in Australia for ten indications across six cancer types. ...
Posted 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. ...