Blog
RSS FeedPosted by Michael Wonder on 12 Nov 2024
Neurotech provides update on BLA for NT-501 as a treatment for macular telangiectasia type 2
8 November 2024 - Neurotech Pharmaceuticals today announced that the US FDA has extended the PDUFA goal date by three months ...
Posted by Michael Wonder on 11 Nov 2024
Pharmas allege Government communication breakdown in medicine deferral crisis
10 November 2024 - Labor has failed to plan for the consequences of delaying drug subsidies and left hundreds of ...
Posted by Michael Wonder on 07 Nov 2024
Government scrambles after medicines delay outrage
6 November 2024 - Health Minister Mark Butler has directed the PBAC to hold an unprecedented extra meeting, after the ...
Posted by Michael Wonder on 06 Nov 2024
Medicine access debacle deepens with invoices for delayed services
5 November 2024 - Pharmaceutical companies whose medicines have been indefinitely delayed are being charged $200,000 per application despite no services ...
Posted by Michael Wonder on 06 Nov 2024
Merus receives FDA extension of PDUFA for zenocutuzumab
5 November 2024 - Merus today announced that the US FDA has extended the PDUFA goal date for zenocutuzumab biologics ...
Posted by Michael Wonder on 05 Nov 2024
Update on FDA review of Vtama (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older
5 November 2024 - Organon today announced that the US FDA extended by three months the target action date of its ...
Posted by Michael Wonder on 29 Oct 2024
Breast Cancer Canada 'Progress Report' reveals major gaps in screening and treatment delays across Canada
28 October 2024 - Breast Cancer Canada has released the 2024 Progress Report on Breast Cancer in Canada. ...
Posted by Michael Wonder on 20 Oct 2024
Intercept provides regulatory update regarding sNDA for Ocaliva
17 October 2024 - Intercept Pharmaceuticals today announced that the US FDA has informed the Company that it is continuing its ...
Posted by Michael Wonder on 08 Oct 2024
Updated information about PHARMAC's priority lists
8 October 2024 - PHARMAC’s quarterly Pūahoaho Report provides the latest information about applications for medicines, vaccines, and related products that ...
Posted by Michael Wonder on 03 Oct 2024
Improving efficiency of approval process for new medicines in the EU
2 October 2024 - EMA and the European medicines regulatory network are working to further improve efficiency in the assessment and ...
Posted by Michael Wonder on 12 Sep 2024
New medicines could be PBS listed in just four weeks under a proposal the health minister calls 'visionary'
11 September 2024 - Have you ever had to wait for an important and expensive medicine to be subsidised? ...
Posted by Michael Wonder on 11 Sep 2024
HTA review outlines First Nations, pediatric reform and quick, cheap medicine
10 September 2024 - A Government review of Australia’s systems for accessing medicine has said it could slash waiting times ...
Posted by Michael Wonder on 07 Sep 2024
KalVista announces FDA acceptance of new drug application for sebetralstat for oral on-demand treatment of hereditary angioedema
3 September 2024 - FDA PDUFA goal date of 17 June 2025. ...
Posted by Michael Wonder on 27 Aug 2024
Soleno Therapeutics announces US FDA acceptance for filing and priority review of NDA for DCCR (diazoxide choline) extended release tablets in Prader-Willi syndrome
27 August 2024 - Soleno Therapeutics today announced that the US FDA has accepted for filing its new drug application ...
Posted by Michael Wonder on 19 Aug 2024
Most expensive treatments remain out of reach without health reform
18 August 2024 - Patients are waiting nearly 600 days to access medicines to which the Therapeutic Goods Administration has ...