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RSS FeedPosted 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 22 Nov 2023
ATAGI recommendations on use of the Moderna and Pfizer monovalent Omicron XBB.1.5 COVID-19 vaccines
20 November 2023 - Recommendations from the Australian Technical Advisory Group on Immunisation on the use of XBB 1.5 COVID-19 vaccines. ...
Posted by Michael Wonder on 20 Nov 2023
New Covid-19 vaccines available to target current variants
20 November 2023 - The Australian Government has accepted the latest advice from the Australian Technical Advisory Group on Immunisation on ...
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 22 Oct 2023
End of COVID-19 emergency response
20 October 2023 - A statement from Australia's Chief Medical Officer, Professor Paul Kelly, on the end of the COVID-19 emergency ...
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 04 Sep 2023
The changing landscape of clinical trials in Australia
4 September 2023 - Examining the clinical trials landscape in Australia is important for governance and to expand knowledge about trial ...
Posted by Michael Wonder on 02 Sep 2023
Additional COVID-19 vaccine dose recommended for adults 75 years and over
1 September 2023 - The Australian Government has accepted advice from the Australian Technical Advisory Group on Immunisation (ATAGI) that all ...
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 25 Jul 2023
Peter Mac increases manufacturing centre for gene therapy bringing new hope to cancer patients
25 July 2023 - Australia’s first biomedical manufacturing facility has opened in Melbourne and will boost lifesaving therapy for cancer patients ...
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 06 Jul 2023
Moderna announces global regulatory submissions for its respiratory syncytial virus (RSV) vaccine, mRNA-1345
5 July 2023 - Moderna has submitted marketing authorization applications for the investigational RSV vaccine, mRNA-1345, with the European Medicines Agency, ...