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 13 Jul 2022
NICE terminates appraisal of belimumab for new indication
13 July 2022 - You guessed it, the sponsor decided not to lodge an evidence submission. ...
Posted by Michael Wonder on 13 Jul 2022
ICER releases draft evidence report on treatments for obesity management
13 July 2022 - Registration now open for 26 July “Early Insights” webinar. ...
Posted by Michael Wonder on 13 Jul 2022
NICE issues final guidance on the use of risankizumab for psoriatic arthritis
13 July 2022 - NICE has published evidence-based recommendations on the use of risankizumab (Skyrizi) for the treatment of adults ...
Posted by Michael Wonder on 13 Jul 2022
Canada making progress in prescription drug coverage
13 July 2022 - Canada has seen a significant improvement in the number of Canadians eligible for some form of prescription ...
Posted by Michael Wonder on 13 Jul 2022
NICE issues final guidance for reimbursement making Vazkepa (icosapent ethyl) available across the NHS in England & Wales
13 July 2022 - Newly published final guidance by NICE in the UK confirms its prior draft recommendation for the use ...
Posted by Michael Wonder on 13 Jul 2022
FDA authorises emergency use of Novavax COVID-19 vaccine, adjuvanted
13 July 2022 - Today, the U.S. FDA issued an emergency use authorisation for the Novavax COVID-19 vaccine, adjuvanted for the ...
Posted by Michael Wonder on 13 Jul 2022
Accelerating pooled licensing of medicines to enhance global production and equitable access
8 July 2022 - From October to November, 2021, the pharmaceutical firms Merck and Pfizer licensed their new COVID-19 oral antiviral ...
Posted by Michael Wonder on 13 Jul 2022
Ancora Heart receives breakthrough device designation from FDA for the AccuCinch ventricular restoration system
12 July 2022 - Designation allows for expedited review of transcatheter therapy designed to improve left ventricular structure and function ...
Posted by Michael Wonder on 13 Jul 2022
Abbott receives FDA breakthrough device designation to explore use of deep brain stimulation to manage severe depression
12 July 2022 - Each year, 2.8 million Americans will fail multiple depression therapies and be diagnosed with treatment-resistant depression. ...
Posted by Michael Wonder on 12 Jul 2022
Alberta expands access to cystic fibrosis drug Trikafta for children 6 to 11
11 July 2022 - Children with cystic fibrosis can now live 'longer, healthier and fuller lives,' says advocate. ...
Posted by Michael Wonder on 12 Jul 2022
Teaching the basics of health technology assessment
11 July 2022 - NICE has launched a free learning course that provides an introduction to health technology assessment. ...
Posted by Michael Wonder on 12 Jul 2022
Healthy.io receives landmark FDA clearance for first and only smartphone powered home kidney test
12 July 2022 - As first test to receive FDA clearance across all current iOS and Android smartphone devices, Minuteful ...
Posted by Michael Wonder on 12 Jul 2022
Provepharm announces that it has received FDA approval for Bludigo (indigotindisulfonate sodium, USP) injection
12 July 2022 - Bludigo is the first and only indigotindisulfonate sodium injection, USP, drug product approved by the FDA. ...
Posted by Michael Wonder on 12 Jul 2022
FDA accepts Byondis' biologics license application for [vic-] trastuzumab duocarmazine (SYD985) in HER2 positive metastatic breast cancer
12 July 2022 - Submission follows positive results of Phase 3 TULIP trial. ...
Posted by Michael Wonder on 12 Jul 2022
Iterum Therapeutics announces special protocol assessment agreement with the FDA
11 July 2022 - SPA supports protocol for Phase 3 clinical trial of oral sulopenem for the treatment of uncomplicated urinary ...