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 26 May 2021
Woebot Health receives FDA breakthrough device designation for post partum depression treatment
26 May 2021 - WB001 is the first digital therapeutic designed to reduce the burden of post partum depression. ...
Posted by Michael Wonder on 26 May 2021
Varian receives FDA breakthrough device designation for its cardiac radioablation system for treatment of refractory ventricular tachycardia
26 May 2021 - Varian's CRA system has been designated a "breakthrough device" by the FDA because of its potential to ...
Posted by Michael Wonder on 26 May 2021
Myovant Sciences and Pfizer receive FDA approval for Myfembree, the first once daily treatment for heavy menstrual bleeding associated with uterine fibroids
26 May 2021 - Myovant and Pfizer will jointly commercialise Myfembree with product availability expected in June. ...
Posted by Michael Wonder on 26 May 2021
130,000 additional vaccines for Victoria
26 May 2021 - The Australian Government is releasing an additional 130,000 vaccines to support Victoria to accelerate vaccinations in the ...
Posted by Michael Wonder on 26 May 2021
Colchester baby's parents feel 'abandoned' over £1.7 million drug
25 May 2021 - A baby with a fatal genetic condition has been "abandoned" in a "race against time" for ...
Posted by Michael Wonder on 26 May 2021
NICE terminates yet another two appraisals
26 May 2021 - This is becoming far too commonplace. ...
Posted by Michael Wonder on 26 May 2021
‘Serious implications’ if menopause treatments removed from PBS
25 May 2021 - Experts warn the proposed delisting of medications will not only impose cost-related issues, but potentially affect quality ...
Posted by Michael Wonder on 26 May 2021
Unity HA awarded breakthrough device designation for implantable neurostimulation technology to treat cluster headache pain
25 May 2021 - Unity HA announced today that the U.S. FDA has granted breakthrough device designation to the Pulsante SPG ...
Posted by Michael Wonder on 26 May 2021
Illuminare-1, a novel nerve visualisation investigational fluorophore, granted fast track designation by U.S. FDA
25 May 2021 - Illuminare Biotechnologies announced that its novel nerve imaging agent, Illuminare-1, has been granted fast track designation by ...
Posted by Michael Wonder on 25 May 2021
TGA decision will ‘open up’ general practice to Pfizer
25 May 2021 - Australia’s medical regulator has said the Comirnaty coronavirus vaccine can now be stored in standard fridges for ...
Posted by Michael Wonder on 25 May 2021
Adjusting for non-adherence or stopping treatments in randomised clinical trials
25 May 2021 - Randomised clinical trials allocate individuals to different treatments, or, more generally, to interventions and comparators, to determine ...
Posted by Michael Wonder on 25 May 2021
Spinal Stabilization Technologies earns FDA breakthrough designation for PerQdisc nucleus replacement system for degenerative disc disease
25 May 2021 - Spinal Stabilization Technologies announced today that it has earned the CE Mark and the FDA's breakthrough ...
Posted by Michael Wonder on 25 May 2021
Jacinda Ardern listening to calls for PHARMAC to fund 13 year old's life-changing drugs, but nothing she can do
25 May 2021 - Prime Minister Jacinda Ardern says she's listening to calls for life-changing drugs to be made more ...
Posted by Michael Wonder on 25 May 2021
President Biden still hasn’t appointed a permanent FDA commissioner. That has big implications for upcoming drug approvals.
25 May 2021 - Within the next few weeks, the FDA is set to make an extraordinary decision: whether or not ...
Posted by Michael Wonder on 25 May 2021
TherapeuticsMD announces submission of low dose Bijuva 0.5 mg/100 mg supplemental new drug application to FDA
25 May 2021 - TherapeuticsMD announced today that the Company submitted a supplemental new drug application for BIJUVA (oestradiol and ...