Blog
RSS FeedPosted by Michael Wonder on 09 Jun 2016
TGA publishes AusPAR for Nuvigil (armodafinil)
9 June 2016 - The TGA has published an AusPAR for Teva's Nuvigil (armodafinil). ...
Posted by Michael Wonder on 06 Jun 2016
TGA publishes 2 new AusPARs
6 June 2016 - The TGA has published AusPARs for talimogene laherparepvec (Imlygic) & naloxegol oxalate (Movantik). ...
Posted by Michael Wonder on 02 Jun 2016
TGA approves lesinurad (Zurampic)
2 June 2016 - The TGA has approved Astra Zeneca's lesinurad (Zurampic). ...
Posted by Michael Wonder on 01 Jun 2016
TGA approves new indication for Perjeta
1 June 2016 - The TGA has approved a new use for Roche's Perjeta (pertuzumab). ...
Posted by Michael Wonder on 26 May 2016
Prescription medicines: TGA annual report for 2015 (part 3 - timelines)
26 May 2016 - The TGA claims it takes, on average, 12 months for the agency to register a new ...
Posted by Michael Wonder on 26 May 2016
TGA updates prescription medicine clinical units
26 May 2016 - The TGA conducts a minor reallocation of prescription medicine authorisation unit work streams. ...
Posted by Michael Wonder on 20 May 2016
TGA approves idarucizumab (Praxbind)
20 May 2016 - The TGA approved idarucizumab (Praxbind) on 11 May 2016. ...
Posted by Michael Wonder on 19 May 2016
TGA approves alirocumab (Praluent)
19 May 2016 - The TGA approved alirocumab (Praluent) on 17 May 2016. ...
Posted by Michael Wonder on 19 May 2016
Prescription medicines: new or extended uses approved by the TGA (May 2016)
19 May 2016 - The TGA has approved new indications for four medicines so far this month. ...
Posted by Michael Wonder on 17 May 2016
Prescription medicines: new or extended uses approved by the TGA
17 May 2016 - The TGA has published a list of the medicines it approved for new uses (new indications) ...
Posted by Michael Wonder on 16 May 2016
TGA publishes AusPAR for Repatha (evolocumab)
16 May 2016 - An AusPAR provides information about the evaluation of a prescription medicine and the considerations that led the ...
Posted by Michael Wonder on 02 May 2016
April 2016 NCE registrations - TGA
2 May 2016 - The TGA registered two new chemical entities (medicines) and two new blood products in April 2016. ...
Posted by Michael Wonder on 02 May 2016
AusPARs user survey
2 May 2016 - The TGA would like to know what you think about the AusPARs for prescription medicines. ...
Posted by Michael Wonder on 12 Apr 2016
TGA publishes 2 new AusPARs
12 April 2016 - The TGA has published Australian Public Assessment Reports (AusPARs) for eltrombopag olamine (Revolade) and the biosimilar for ...
Posted by Michael Wonder on 06 Apr 2016
March 2016 NCE registrations - TGA
7 April 2016 - The TGA registered three new medicines and one new combination product in March 2016: lumacaftor with ...