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 04 Aug 2021
Court topples Canadian ruling that one of world's most expensive drugs is excessively priced
3 August 2021 - Soliris was originally approved to treat two blood disorders affecting about 180 Canadians, with the list price ...
Posted by Michael Wonder on 04 Aug 2021
New CAR T-cell therapy option now available in Australia for patients with aggressive blood cancer
5 August 2021 - Eligible patients can now access Yescarta through Peter MacCallum Cancer Centre, Melbourne and Royal Brisbane and Women’s ...
Posted by Michael Wonder on 04 Aug 2021
Federal watchdog will review the controversial FDA approval of Biogen’s Alzheimer’s drug
4 August 2021 - The federal watchdog at the Department of Health and Human Services will review the process used ...
Posted by Michael Wonder on 04 Aug 2021
Cerus Corporation announces CMS has granted new technology add-on payment for INTERCEPT fibrinogen complex
3 August 2021 - New technology add-on payment provides incremental reimbursement under CMS’ Inpatient Prospective Payment System for INTERCEPT Fibrinogen Complex. ...
Posted by Michael Wonder on 04 Aug 2021
New collaboration between NICE and The Academic Health Science Network will help embed innovations into the healthcare system for the benefit of patients
4 August 2021 - The agreement will draw on the strengths, skills, and resources of both organisations in order to seize ...
Posted by Michael Wonder on 04 Aug 2021
Kestra Medical Technologies receives FDA premarket approval for ASSURE wearable cardioverter defibrillator
3 August 2021 - Kestra Medical Technologies announced today that the company has received U.S. FDA premarket approval for the ASSURE ...
Posted by Michael Wonder on 04 Aug 2021
Collecting patient reported outcomes in cancer clinical trials
3 August 2021 - To help patients with cancer learn more about how treatment may affect their quality of life, the ...
Posted by Michael Wonder on 04 Aug 2021
FDA reportedly hopes to fully approve Pfizer’s Covid vaccine by Labor Day
3 August 2021 - Federal regulators are aiming to grant full approval to Pfizer’s coronavirus vaccine by early September, the New ...
Posted by Michael Wonder on 04 Aug 2021
Interpreting the results of intention to treat, per protocol and as treated analyses of clinical trials
3 August 2021 - Non-adherence in a randomised clinical trial occurs when study participants do not follow the randomly assigned treatment ...
Posted by Michael Wonder on 04 Aug 2021
FDA regulation and approval of medical devices: 1976-2020
3 August 2021 - US law generally requires testing of high-risk medical devices prior to approval, as well as pre-market evaluation ...
Posted by Michael Wonder on 04 Aug 2021
FDA grants breakthrough device designation status for Hancock Jaffe's VenoValve
3 August 2021 - VenoValve is a potential treatment for approximately 2.4 million U.S. patients that suffer from severe chronic venous ...
Posted by Michael Wonder on 04 Aug 2021
Abbott receives FDA clearance for its imaging technology using artificial intelligence for vessels in the heart
3 August 2021 - Ultreon 1.0 software, the first-of-its-kind imaging software, merges optical coherence tomography with the power of automation using ...
Posted by Michael Wonder on 04 Aug 2021
Regulating digital health apps needs user-centered reform
3 August 2021 - When people seek health information, they expect what they get to be reliable and accurate. ...
Posted by Michael Wonder on 04 Aug 2021
MHRA approves first immunotherapy treatment for mesothelioma
3 August 2021 - The MHRA has approved the combination of nivolumab plus ipilimumab for the first-line treatment of adult ...
Posted by Michael Wonder on 03 Aug 2021
Moderna receives FDA fast track designation for respiratory syncytial virus vaccine (mRNA-1345)
3 August 2021 - Moderna today announced that the U.S. FDA has granted fast track designation for mRNA-1345, its investigational ...