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 11 Aug 2022
Genentech announces FDA approval of Xofluza to treat influenza in children aged five and older
11 August 2022 - The FDA also approved Xofluza to prevent influenza in children aged five and older following contact with ...
Posted by Michael Wonder on 11 Aug 2022
The FDA’s ‘breakthrough’ medical devices are finally hitting the market in numbers
11 August 2022 - The Breakthrough Device Program is approaching terminal velocity. ...
Posted by Michael Wonder on 11 Aug 2022
Understanding the Democrats’ drug pricing package
10 August 2022 - On Sunday, the Senate passed the Inflation Reduction Act (IRA) of 2022, which includes comprehensive reforms to ...
Posted by Michael Wonder on 11 Aug 2022
Amgen's acute lymphoblastic leukaemia drug Blincyto passes reimbursement review
11 August 2022 - Amgen's acute lymphoblastic leukaemia treatment Blincyto (blinatumomab) passed the reimbursement review about two years after expanding ...
Posted by Michael Wonder on 11 Aug 2022
Menarini Group’s elacestrant granted priority review by the US FDA for patients with ER+/HER2- advanced or metastatic breast cancer
11 August 2022 - US FDA has assigned a Prescription Drug User Fee Act date of 17 February 2023. ...
Posted by Michael Wonder on 11 Aug 2022
European Commission approves Imbruvica (ibrutinib) fixed duration combination for adult patients with previously untreated chronic lymphocytic leukaemia
9 August 2022 - It is the first all oral, fixed duration, once daily treatment based on a Bruton's tyrosine kinase ...
Posted by Michael Wonder on 11 Aug 2022
Roche receives FDA approval for VENTANA MMR RxDx panel to identify dMMR solid tumour patients and pMMR endometrial cancer patients eligible for Keytruda
11 August 2022 - Based on cancer biomarkers, the first-of-its-kind VENTANA MMR RxDx Panel helps identify solid tumour patients, including endometrial ...
Posted by Michael Wonder on 10 Aug 2022
Failed COVIDSafe app deleted
10 August 2022 - The Albanese Government has acted to delete the wasteful and ineffective COVIDSafe app. ...
Posted by Michael Wonder on 10 Aug 2022
Real-world data can help expedite drug approvals for serious diseases with few options
10 August 2022 - My grandmother was diagnosed with dementia in the early 2000s. We started taking it seriously when she ...
Posted by Michael Wonder on 10 Aug 2022
The situation in New Zealand can only be described as dire
11 August 2022 - The available evidence for 2022 suggests the innovative pharmaceutical industry has very little interested in preparing/lodging ...
Posted by Michael Wonder on 10 Aug 2022
Cure Rare Disease receives FDA approval to administer first in human CRISPR therapeutic
10 August 2022 - Cure Rare Disease announces the approval from the US FDA to administer its very first therapeutic. ...
Posted by Michael Wonder on 10 Aug 2022
Overall survival, progression-free survival and tumour response benefit supporting initial US FDA approval and indication extension of new cancer drugs, 2003-2021
10 August 2022 - Clinical trial evidence is routinely evaluated for initial drug approvals, yet the benefit of indication extensions remains ...
Posted by Michael Wonder on 10 Aug 2022
EU regulator begins review of Pfizer-BioNTech's variant adapted COVID shot
9 August 2022 - The EMA has started a rolling review of a variant-adapted COVID-19 vaccine from Pfizer and BioNTech, ...
Posted by Michael Wonder on 10 Aug 2022
Few U.S. patients with hepatitis C get timely treatment, CDC says
9 August 2022 - Few U.S. adults diagnosed with hepatitis C virus infection receive timely treatment with anti-viral drugs, the ...
Posted by Michael Wonder on 10 Aug 2022
FDA authorises emergency use of Jynneos vaccine to increase vaccine supply
9 August 2022 - Today, the U.S. FDA issued an emergency use authorisation for the Jynneos vaccine to allow health care ...