Blog
RSS FeedPosted by Michael Wonder on 16 Apr 2024
Norgine submits marketing authorisation application via Project Orbis for eflornithine (difluoromethylornithine) in high-risk neuroblastoma
15 April 2024 - Norgine today announced its first marketing authorisation application submissions on 10 April 2024, seeking approval for eflornithine ...
Posted by Michael Wonder on 29 Feb 2024
Regulator acts to close loophole enabling Australian pharmacists to make copycat Ozempic drug
29 February 2024 - The TGA will move to ban compounding pharmacists from making their own versions of injectable weight ...
Posted by Michael Wonder on 24 Feb 2024
Shortage of migraine medication crushing for chronic pain patients
23 February 2024 - A migraine medication shortage has spread across the country, threatening to leave tens of thousands of ...
Posted by Michael Wonder on 22 Feb 2024
TGA approves new medication for treatment of endometriosis symptoms
23 February 2024 - Australian drug regulator gives company green light for tablet – although it won’t be subsidised by Pharmaceutical ...
Posted by Michael Wonder on 03 Dec 2023
Junshi Biosciences announces new chemical entity application for toripalimab accepted by Australia’s TGA
1 December 2023 - Shanghai Junshi Biosciences announced that the TGA has accepted the new chemical entity application for toripalimab in ...
Posted by Michael Wonder on 12 Nov 2023
MedChem a game changer in identifying lifesaving new drugs
8 November 2023 - The Australian Government is ensuring the next generation of lifesaving drugs and world-class medical treatments can be ...
Posted by Michael Wonder on 04 Nov 2023
Hormone replacement therapy patch shortages are having a big impact on the women who need them
4 November 2023 - Women are being thrust back into the most severe stages of menopause amid long-running national shortages of ...
Posted 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 ...