Blog
RSS FeedPosted by Michael Wonder on 03 Oct 2024
KalVista announces the submission of additional marketing authorisation applications for sebetralstat for the oral on-demand treatment of hereditary angioedema
30 September 2024 - If approved, sebetralstat will be the first, oral on-demand treatment for HAE. ...
Posted by Michael Wonder on 14 Mar 2021
Approval of updated storage conditions for the Pfizer COVID-19 vaccine
13 March 2021 - The TGA has received and assessed additional data submitted by Pfizer for their COVID-19 vaccine (COMIRNATY - ...
Posted by Michael Wonder on 10 Nov 2020
Mirum Pharmaceuticals broadens Expanded Access Program for maralixibat in Alagille syndrome to Europe and Australia
5 November 2020 - Maralixibat Expanded Access Program now available for patients with pruritus associated with Alagille syndrome in Australia and ...
Posted by Michael Wonder on 28 Mar 2018
Mylan and Biocon receive approvals from the European Commission and TGA Australia for Semglee, biosimilar insulin glargine
27 March 2018 - Mylan and Biocon today announced that their co-developed biosimilar insulin glargine Semglee has received marketing authorisation ...
Posted by Michael Wonder on 06 Aug 2016
More on the transparency of public assessment reports in Europe and Australia
6 August 2016 - The TGA and EMA have recently described their experiences in publishing public assessment reports, and reflect ...
Posted by Michael Wonder on 05 Aug 2016
TGA publishes paper on transparency in medicines regulation
5 August 2016 - Co-authoring with the EMA, the TGA has published a peer-reviewed, free-to-view paper on transparency in medicines regulation. ...