Blog
RSS FeedPosted by Michael Wonder on 14 Apr 2021
TGA grants provisional determination to GSK for COVID-19 monoclonal antibody treatment - sotrovimab
14 April 2021 - The TGA has granted a provisional determination to GSK in relation to the monoclonal antibody treatment, ...
Posted by Michael Wonder on 30 Mar 2021
Terminal cancer patients denied new treatments due to slow TGA approval
31 March 2021 - Desperate cancer patients are begging Australia’s drugs regulator to save lives by speeding up approvals and cutting ...
Posted by Michael Wonder on 29 Mar 2021
Building a more robust medicine supply - proposals to help prevent, mitigate and manage medicine shortages
29 March 2021 - The Therapeutic Goods Administration is conducting a public consultation seeking feedback on reforms intended to help ...
Posted by Michael Wonder on 24 Mar 2021
Vertex receives Australian TGA approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to treat people with cystic fibrosis ages 12 years and older who have at least one F508del mutation
24 March 2021 - With this approval approximately 750 people living with cystic fibrosis in Australia will be newly eligible for ...
Posted by Michael Wonder on 10 Mar 2021
Australia’s Therapeutic Goods Administration approves Feraccru to treat iron deficiency with or without anaemia in adults
9 March 2021 - Shield Therapeutics notes that Australia’s Therapeutic Goods Administration has registered Feraccru in the Australian Register of ...
Posted by Michael Wonder on 10 Mar 2021
TGA approves Zolgensma
10 March 2021 - Onasemnogene abeparvovec is a new gene therapy for children with spinal muscular atrophy. ...
Posted by Michael Wonder on 05 Mar 2021
New legislation to support medicine substitutions
5 March 2021 - New legislation has been passed to allow pharmacists to substitute a different medicine when a patient's ...
Posted by Michael Wonder on 15 Feb 2021
TGA approves new formulation of glatiramer acetate
16 February 2021 - The TGA thinks glatiramer acetate (Glatopa) is a new chemical entity. ...
Posted by Michael Wonder on 15 Feb 2021
One billion dollar bid to go it alone with COVID-19 vaccine hub
15 February 2021 - A proposal for a state-of-the-art $1 billion facility to manufacture vaccines and prescription drugs in Australia ...
Posted by Michael Wonder on 08 Feb 2021
TGA one of only five non-European regulators invited to participate on European committees on COVID-19 vaccines and therapeutics
8 February 2021 - Australia, through the TGA, is one of only five non-European Union regulators formally invited to participate ...
Posted by Michael Wonder on 04 Feb 2021
Repurposing of prescription medicines
4 February 2021 - The Therapeutic Goods Administration is conducting a public consultation that seeks to understand potential obstacles and ...
Posted by Michael Wonder on 03 Feb 2021
Cost recovery implementation statement (2020-2021)
3 February 2021 - This Cost Recovery Implementation Statement provides information on how the Therapeutic Goods Administration, within the Department of ...
Posted by Michael Wonder on 02 Feb 2021
Precision medicine helping to change the prognosis of a rare subtype of bowel cancer
2 February 2021 - Australians with a specific type of bowel cancer are no longer subject to a ‘one-size fits ...
Posted by Michael Wonder on 30 Jan 2021
TGA approves first new medicine for 2021
31 January 2021 - The TGA approved Aklief (trifarotene) for the topical treatment of acne vulgaris of the face and/or the ...
Posted by Michael Wonder on 28 Jan 2021
TGA to rule on psychedelic drug access for mental health problems
28 January 2021 - A group of prominent Australians is continuing to push for greater access to psychedelic drugs to ...