Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 04 Jun 2020
New small cell lung cancer drug accepted for TGA evaluation under Project Orbis
3 June 2020 - TGA has granted provisional designation for new drug lurbinectedin based on encouraging Phase 2 results and high ...
Posted by Michael Wonder on 28 May 2020
Off-label drugs a risky business
28 May 2020 - Three years ago a 64cm blood clot caused by a drug used to treat acne, Diane ...
Posted by Michael Wonder on 25 May 2020
TGA approves Rozlytrek
25 May 2020 - Roche secures TGA approval for another cancer medicine. ...
Posted by Michael Wonder on 12 May 2020
ZolpiMist update
12 May 2020 - SUDA submitted a marketing authorisation application to the TGA for ZolpiMist in April 2019. ...