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 12 Aug 2021
Reclassification of software based medical devices
12 August 2021 - Recent changes to regulation of software based medical devices came into effect in early 2021, which ...
Posted by Michael Wonder on 12 Aug 2021
COVID-19 vaccine weekly safety report (12 August 2021)
12 August 2021 - To 8 August 2021, approximately 13.7 million vaccine doses have been given in Australia – 9.1 million ...
Posted by Michael Wonder on 12 Aug 2021
FDA approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) combination for first-line treatment of adult patients with advanced renal cell carcinoma
11 August 2021 - Keytruda plus Lenvima is now approved for two types of cancer, including advanced renal cell carcinoma. ...
Posted by Michael Wonder on 11 Aug 2021
‘We don’t unlearn’: what the pandemic has taught regulators about real world data
11 August 2021 - During the pandemic, regulatory agencies deployed emergency measures left and right to speed care to patients. ...
Posted by Michael Wonder on 11 Aug 2021
Groups make own drugs to fight high drug prices, shortages
11 August 2021 - Impatient with years of inaction in Washington on prescription drug prices, U.S. hospital groups, start-ups and ...
Posted by Michael Wonder on 11 Aug 2021
New Alzheimer's drug aducanumab is dividing doctors and patients, as the TGA weighs up its risk-benefit profile
12 August 2021 - After a decades-long career as a biology teacher, John Rodgers applies the strict logic of a ...
Posted by Michael Wonder on 11 Aug 2021
Withdrawals from the pharmaceutical benefits on 1 September 2021
10 August 2021 - Faslodex is among the medicines being withdrawn from the drug benefits on 1 September 2021. ...
Posted by Michael Wonder on 11 Aug 2021
Vulnerable Senate Democrats escalate a push for Medicare to negotiate drug prices
11 August 2021 - Five of the most vulnerable Democrats in the Senate on Tuesday publicly renewed their push to ...
Posted by Michael Wonder on 11 Aug 2021
Veterans Affairs declines to cover Biogen’s Alzheimer’s drug over effectiveness, safety concerns
11 August 2021 - The Department of Veterans Affairs has decided not to cover a new Alzheimer’s drug from Biogen, ...
Posted by Michael Wonder on 11 Aug 2021
Turning Point Therapeutics granted sixth regulatory designation for repotrectinib
11 August 2021 - Fast track designation granted by FDA in ROS1 positive advanced non-small-cell lung cancer patients pretreated with one ...
Posted by Michael Wonder on 11 Aug 2021
Swing Therapeutics receives FDA breakthrough device designation for digital therapeutic for the management of fibromyalgia, launches real world study
11 August 2021 - Approach based on acceptance and commitment therapy and a foundational clinically validated digital program licensed from University ...
Posted by Michael Wonder on 11 Aug 2021
Update on US regulatory review of roxadustat in anaemia of chronic kidney disease
11 August 2021 - The US FDA has issued a complete response letter regarding the new drug application for roxadustat ...
Posted by Michael Wonder on 11 Aug 2021
Pressure builds for full FDA approval of vaccines
11 August 2021 - Pressure is building for the FDA to fully approve the COVID-19 vaccine, a step that could ...
Posted by Michael Wonder on 11 Aug 2021
TGA head John Skerritt says NSW death toll would be much higher without AstraZeneca vaccine
11 August 2021 - The head of the national medical regulator says NSW would be recording “dozens” of covid deaths a ...
Posted by Michael Wonder on 11 Aug 2021
Medicare expansion and a lower eligibility age are included in Democrats’ $3.5 trillion budget plan
9 August 2021 - There’s no guarantee that these proposals will make it through the full legislative process. ...