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
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 ...
Posted by Michael Wonder on 12 Jul 2022
FDA rule would facilitate prescription to OTC switches but nix a third class of drugs
12 July 2022 - After a decade long wait, the FDA finally issued a proposed rule in late June that ...
Posted by Michael Wonder on 12 Jul 2022
EMA launches pilot project on analysis of raw data from clinical trials
12 July 2022 - EMA has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical ...
Posted by Michael Wonder on 12 Jul 2022
Hansa Biopharma announces first patient treated in the post-authorisation efficacy study of Idefirix (imlifidase) in highly sensitised kidney transplant patients
11 July 2022 - The study is an obligation under the conditional marketing authorisation for Idefirix granted by the EMA ...
Posted by Michael Wonder on 11 Jul 2022
Perrigo's HRA Pharma submits application to FDA for first ever OTC birth control pill
11 July 2022 - Perrigo today announced that HRA Pharma, a Perrigo company, has submitted its application to the U.S. ...
Posted by Michael Wonder on 11 Jul 2022
CADTH Advisory Panel report recommends framework for potential pan-Canadian formulary
11 July 2022 - In July 2021, the Government of Canada approached CADTH to develop a recommended framework for creating and ...
Posted by Michael Wonder on 11 Jul 2022
PHARMAC ‘procrastinating’ over funding glucose monitors, Diabetes NZ says
12 July 2022 - PHARMAC should stop procrastinating on funding glucose monitors for people with diabetes after the Government agency ...
Posted by Michael Wonder on 11 Jul 2022
T2 Biosystems receives FDA breakthrough device designation for the T2Lyme panel
11 July 2022 - Molecular diagnostic test for early detection of Lyme disease. ...