Blog
RSS FeedPosted by Michael Wonder on 23 Jun 2021
TGA approves first generic pomalidomide
23 June 2021 - The TGA has approved first generic version of Celgene's Pomalyst. ...
Posted by Michael Wonder on 09 Jun 2021
New Alzheimer’s drug unlikely to be approved in Australia soon, say experts
9 June 2021 - A controversial new drug that has offered hope to Alzheimer’s sufferers by slowing cognitive decline still ...
Posted by Michael Wonder on 09 Jun 2021
Glaukos Announces Australia’s TGA regulatory approval for Preserflo MicroShunt
8 June 2021 - Glaukos Corporation today announced that the TGA has granted regulatory approval for the Preserflo MicroShunt intended for ...
Posted by Michael Wonder on 25 May 2021
TGA approves more flexible storage conditions for Pfizer-BioNTech COVID-19 vaccine
24 May 2021 - Today, the TGA approved an application from Pfizer to change its current storage conditions for its ...
Posted by Michael Wonder on 24 May 2021
Gilead withdraws submission for Jyseleca
24 May 2021 - Decision should not come as a major surprise given FDA rejection last year. ...
Posted by Michael Wonder on 13 May 2021
Provisional determination granted to Pfizer in relation to COVID 19 vaccine (Comirnaty) - for use in individuals 12 years of age and older
13 May 2021 - On 11 May 2021, the Therapeutic Goods Administration granted a provisional determination to Pfizer Australia in ...
Posted by Michael Wonder on 12 May 2021
TGA approves Octapharma's Cutaquig
12 May 2021 - The TGA has deemed it to be a new biological entity. Others will beg to differ. ...
Posted by Michael Wonder on 04 May 2021
TGA approves new treatment for aggressive form of prostate cancer
5 May 2021 - The TGA has registered a new medication to treat a particularly aggressive and advanced type of ...
Posted by Michael Wonder on 04 May 2021
Australia's TGA grants approval to first objective concussion diagnostic
4 May 2021 - Oculogica's EyeBOX is the only objective diagnostic cleared by the US FDA and Australia TGA as an ...
Posted by Michael Wonder on 03 May 2021
TGA approves key label updates to Buvidal for treatment of opioid dependence
3 May 2021 - Camurus today announced that the Australian regulatory agency, the TGA, has approved key label updates to ...
Posted by Michael Wonder on 26 Apr 2021
Global sarcoma therapy now approved for Australian patients
23 April 2021 - Globally regarded soft tissue sarcoma therapy has been approved by the Therapeutic Goods Administration for Australian patients. ...
Posted 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 08 Apr 2021
Wider storage and transportation conditions for the Pfizer COVID-19 vaccine now approved
8 April 2021 - The Therapeutic Goods Administration has recently approved wider storage and transportation conditions for the Pfizer COVID-19 ...
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 24 Mar 2021
Super flu vaccine gets the go-ahead
24 March 2021 - A new type of cell-based influenza vaccine is available this winter that promises to be significantly ...