Blog
RSS FeedPosted by Michael Wonder on 28 Sep 2023
Akebia announces approval of Vafseo (vadadustat) in Australia
26 September 2023 - Akebia Therapeutics today announced that Australia's TGA has granted approval for Vafseo (vadadustat), an oral hypoxia-inducible ...
Posted by Michael Wonder on 24 Sep 2023
New rules for weight loss ‘wonder drug’ after regulator clamp down
23 September 2023 - Australia’s pharmaceuticals regulator has ushered in new rules for a diabetes drug, which is being hailed by ...
Posted by Michael Wonder on 01 Sep 2023
Celltrion applies for Australian approval for Stelara biosimilar
31 August 2023 - Celltrion said it has completed a marketing authorisation application for CT-P43, a biosimilar referencing Stelara (ustekinumab) ...
Posted by Michael Wonder on 12 Jul 2023
Idefirix (imlifidase) receives provisional approval in Australia as desensitisation treatment in highly sensitised patients prior to kidney transplantation
11 July 2023 - Regulatory milestone marks the first time Idefirix has been approved in kidney transplantation from both living ...
Posted by Michael Wonder on 10 Jul 2023
TGA decision on access to medical terminations
11 July 2023 - The Government welcomes the TGA’s decision to remove a number of restrictions on health professionals who ...
Posted by Michael Wonder on 29 Jun 2023
Lymphoma therapy now approved for Australian patients with diffuse large B-cell lymphoma
28 June 2023 - Recent five-year follow-up data from Phase 2 L-MIND investigation showed patients treated with Minjuvi had prolonged, ...
Posted by Michael Wonder on 04 Jun 2023
TGA supports MHRA’s new international recognition framework for medicines
2 June 2023 - As a trusted regulatory partner, TGA is committed to support the new international recognition framework that MHRA ...
Posted by Michael Wonder on 30 May 2023
‘A victim of its own success’: inside the great Ozempic shortage
26 May 2023 - The drug is approved in Australia to treat type 2 diabetes but people have flocked to it ...
Posted by Michael Wonder on 27 Mar 2023
TGA’s new powers will help reduce the impact of medicine shortages on patients
24 March 2023 - From 22 March 2023, the TGA can approve the temporary import or supply of an overseas approved ...
Posted by Michael Wonder on 25 Mar 2023
Lapse of provisional registration for Tecentriq (atezolizumab) for the treatment of locally advanced or metastatic triple negative breast cancer
22 March 2023 - On 22 March 2023, the provisional registration of Tecentriq (atezolizumab) for the treatment of mTNBC will ...
Posted by Michael Wonder on 02 Feb 2023
Professor John Skerritt retirement
2 February 2023 - Today, Professor John Skerritt has announced his decision to retire from his position of Deputy Secretary ...
Posted by Michael Wonder on 01 Feb 2023
Changes applying to evaluation of new substances for listed medicines
1 February 2023 - The TGA has introduced Mandatory requirements for applications to vary the Permissible Ingredients Determination under section 26BD ...
Posted by Michael Wonder on 30 Jan 2023
Life sciences industry calls for better funding for medicine and technology regulator
31 January 2023 - The life sciences, health and medicine sectors have come together to call for improved funding of ...
Posted by Michael Wonder on 26 Jan 2023
Evolus receives regulatory approval for Nuceiva in Australia
23 January 2023 - Australia among the largest countries in the world for aesthetic neurotoxins. ...
Posted by Michael Wonder on 16 Jan 2023
The game-changing plan to cut barriers to medical abortion
16 January 2023 - A push is under way to make medical abortion more accessible across Australia by cutting down ...