Blog
RSS FeedPosted by Michael Wonder on 08 Jun 2022
The UK MHRA, Australian TGA and Health Canada approve Kimmtrak (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma
8 June 2022 - Kimmtrak demonstrated statistically and clinically meaningful overall survival benefit, hazard ratio of 0.51, with median overall survival ...
Posted by Michael Wonder on 22 Jun 2021
Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium
22 June 2021 - The TGA is a member of the Access consortium along with Health Canada, Health Sciences Authority of ...
Posted by Michael Wonder on 21 Nov 2019
FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukaemia
21 November 2019 - Today, as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, ...
Posted by Michael Wonder on 01 Nov 2018
Update on the Australia-Canada Mutual Recognition Agreement
1 November 2018 - Common Statement regarding inclusion of Active Pharmaceutical Ingredient in Australia-Canada Mutual Recognition Agreement (as of November 1, ...
Posted by Michael Wonder on 10 Jul 2018
Medicines Australia welcomes priority review pathway programme milestone
10 July 2018 - Last week saw the listing of Eryland (apalutamide) for the treatment men with non-metastatic (castration-resistant) prostate ...
Posted by Michael Wonder on 05 Jul 2018
International work-sharing pilot - apalutamide (Erlyand)
5 July 2018 - Apalutamide (Erlyand) is the first medicine to be registered on the Australian Register of Therapeutic Goods ...
Posted by Michael Wonder on 17 Apr 2018
ACSS - NCE work-sharing pilot
17 April 2018 - The ACSS Consortium is a collaborative initiative of like-minded, medium-sized regulatory authorities between Australia's Therapeutic Goods Administration, ...