Blog
RSS FeedPosted by Michael Wonder on 19 Aug 2020
Inquiry into approval processes for new drugs and novel medical technologies in Australia
19 August 2020 - Following a referral on 13 August 2020 from the Minister for Health, The Hon Greg Hunt ...
Posted by Michael Wonder on 13 Aug 2020
Seattle Genetics announces Tukysa (tucatinib) approved within months for all countries participating in FDA’s Project Orbis initiative
12 August 2020 - Australia joins U.S., Switzerland, Canada and Singapore in approval of Tukysa for the treatment of patients with ...
Posted by Michael Wonder on 11 Aug 2020
Local doctor may have breakthrough coronavirus cure
11 August 2020 - Local doctor Thomas Borody has found what may be a cheap and easy treatment for COVID-19 patients ...
Posted by Michael Wonder on 11 Aug 2020
Alkindi approved in Australia
10 August 2020 - Diurnal Group announces that Alkindi (hydrocortisone granules in capsules for opening) has been approved by the ...
Posted by Michael Wonder on 05 Aug 2020
Anavex Life Sciences receives TGA Special Access Scheme approval for Anavex 2-73 (blarcamesine) for Alzheimer’s disease patients
5 August 2020 - Compassionate use Special Access Scheme approval for Alzheimer’s patients to continue treatment with Anavex 2-73 (blarcamesine) after ...
Posted by Michael Wonder on 29 Jul 2020
TGA approves new medicine for basal cell carcinoma
29 July 2020 - Cemiplimab (Libtayo) has been provisionally registered by the TGA. ...
Posted by Michael Wonder on 27 Jul 2020
TGA approves Zeposia for patients with multiple sclerosis
27 July 2020 - Zeposia has been approved under the Black Triangle Scheme. ...
Posted by Michael Wonder on 15 Jul 2020
Deciphera announces Australian Therapeutic Goods Administration’s approval of Qinlock (ripretinib) for the treatment of fourth-line gastro-intestinal stromal tumour
14 July 2020 - Qinlock is the first approved tyrosine kinase inhibitor designed specifically for GIST regardless of patients’ mutational status. ...
Posted by Michael Wonder on 14 Jul 2020
Gilead rushes to meet remdesivir demand as virus pressures grow
15 July 2020 - Global pharmaceuticals giant Gilead has flagged the supply of its coronavirus treatment remdesivir will be constrained ...
Posted by Michael Wonder on 13 Jul 2020
TGA publishes more details on its approval of COVID-19 medicine Veklury
13 July 2020 - Remdesivir granted conditional approval in record time. ...
Posted by Michael Wonder on 11 Jul 2020
Australia's first COVID treatment approved
10 July 2020 - The Therapeutic Goods Administration has granted provisional approval to remdesivir (Veklury, Gilead Sciences) as the first ...
Posted by Michael Wonder on 24 Jun 2020
US painkiller to be sold in Australian pharmacies to shore up supply
25 June 2020 - Global pharmaceutical giant Johnson & Johnson has been given approval to sell its US painkiller brand ...
Posted by Michael Wonder on 23 Jun 2020
Submissions received: fees and charges proposal 2020-21
23 June 2020 - On 20 January 2020, the Therapeutic Goods Administration (TGA) released on its website a consultation paper, ...
Posted by Michael Wonder on 22 Jun 2020
Anti-COVID drug may be ready in Australia by the end of the year
21 June 2020 - A global breakthrough on a new antiviral drug that scientists believe could block the coronavirus has ...
Posted by Michael Wonder on 18 Jun 2020
Fees and charges: summary from 1 July 2020
18 June 2020 - The TGA is required to recover its costs for all activities that fall within the scope of ...