Blog
RSS FeedPosted by Michael Wonder on 11 Dec 2024
Theratechnologies receives March 2025 PDUFA goal date for updated tesamorelin F8 formulation sBLA
10 December 2024 - Theratechnologies today announced that the US FDA has assigned a PDUFA goal date of 25 March ...
Posted by Michael Wonder on 11 Dec 2024
Krystal Biotech provides update on EMA’s on-going regulatory review of B-VEC for dystrophic epidermolysis bullosa
9 December 2024 - CHMP opinion now expected in Q1, 2025. ...
Posted by Michael Wonder on 04 Dec 2024
Soleno Therapeutics announces FDA extension of review period for DCCR (diazoxide choline) extended release tablets in Prader-Willi syndrome
26 November 2024 - PDUFA target action date extended by three months to 27 March 2025. ...
Posted by Michael Wonder on 01 Dec 2024
Voters clamour for affordable health in election lead-up
30 November 2024 - Threats and delays to affordable medicine access underscore an appetite for higher health spending, with polling placing ...
Posted by Michael Wonder on 12 Nov 2024
Unicycive Therapeutics announces US FDA acceptance of the new drug application for oxylanthanum carbonate for the treatment of hyperphosphataemia in patients with chronic kidney disease on dialysis
11 November 2024 - FDA sets PDUFA action date of 28 June 2025. ...
Posted 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 ...