Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 01 Dec 2020
Genentech announces FDA approval of Xolair (omalizumab) for adults with nasal polyps
1 December 2020 - Xolair is the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E, ...
Posted by Michael Wonder on 01 Dec 2020
Australia's 10 most commonly prescribed medicines revealed by PBS data
1 December 2020 - Australians continue to use statins more than any other prescription drug, with the two most common ...
Posted by Michael Wonder on 01 Dec 2020
Outraged patients to present petition with over 30,000 signatures to ask for funding for desperately needed medication
2 December 2020 - Sick of waiting for years for PHARMAC to fund standard, current therapy to treat their diseases, ...
Posted by Michael Wonder on 01 Dec 2020
US hopeful of pre-Christmas COVID jab, Australia still has long wait
1 December 2020 - Millions of vulnerable Americans could be vaccinated against coronavirus before the end of 2020 but it ...
Posted by Michael Wonder on 01 Dec 2020
FDA approves pralsetinib for RET altered thyroid cancers
1 December 2020 - Today the Food and Drug Administration approved pralsetinib (Gavreto, Blueprint Medicines) for adult and pediatric patients ...
Posted by Michael Wonder on 01 Dec 2020
EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2
1 December 2020 - EMA has received an application for conditional marketing authorisation for BNT162b2, a COVID‑19 mRNA vaccine developed by ...
Posted by Michael Wonder on 01 Dec 2020
FDA approves first PSMA-targeted PET imaging drug for men with prostate cancer
1 December 2020 - Today, the U.S. FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for ...
Posted by Michael Wonder on 01 Dec 2020
EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine
1 December 2020 - EMA has received an application for conditional marketing authorisation for a COVID-19 mRNA vaccine by Moderna Biotech. ...
Posted by Michael Wonder on 01 Dec 2020
Innovative technology to detect abnormal heart rhythms recommended by NICE for NHS use while further data is collected
1 December 2020 - Zio ZT is the first assessment, via the NICE digital health technologies guidance development pilot project, to ...
Posted by Michael Wonder on 01 Dec 2020
Mirum Pharmaceuticals announces European Medicines Agency validation of the marketing authorisation application for maralixibat in patients with PFIC2
30 November 2020 - Five-year transplant-free survival data from the Phase 2 INDIGO study used as the basis for the MAA ...
Posted by Michael Wonder on 01 Dec 2020
ARS announces acceptance of market authorisation application submission to European Medicines Agency for Neffy (ARS-1; epinephrine nasal spray)
30 November 2020 - ARS Pharmaceuticals announced today that the EMA has accepted a marketing authorisation application submission for review of ...
Posted by Michael Wonder on 01 Dec 2020
Kadmon announces FDA acceptance of NDA for belumosudil in patients with chronic graft versus host disease
30 November 2020 - Application being evaluated Under FDA's Real-Time Oncology Review and Project Orbis pilot programs. ...
Posted by Michael Wonder on 01 Dec 2020
ICER releases draft evidence report on therapies for anaemia in chronic kidney disease
30 November 2020 - Public comment period now open until 5 January 2021; requests to make oral comment during public meeting ...
Posted by Michael Wonder on 01 Dec 2020
Karolinska Development's portfolio company Aprea Therapeutics receives FDA fast track designation for eprenetapopt in AML
30 November 2020 - Karolinska Development announces today that the U.S. FDA has granted fast track designation for eprenetapopt in the ...
Posted by Michael Wonder on 30 Nov 2020
Now more than ever, the fight against HIV must continue
1 December 2020 - To mark World AIDS Day 2020 and support the ‘now more than ever’ theme, the Morrison Government ...