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 16 Feb 2023
Delcath Systems announces new drug application resubmission for Hepzato Kit
14 February 2023 - Delcath Systems announced it submitted a new drug application resubmission to the US FDA for the ...
Posted by Michael Wonder on 16 Feb 2023
Tixagevimab and cilgavimab for the the prevention of COVID-19 disease
16 February 2023 - The Department of Health and Social Care has NICE to produce guidance on the use of ...
Posted by Michael Wonder on 15 Feb 2023
US Government payer funded trials to address oncology's drug dosing conundrum: a Congressional call to action?
13 February 2023 - Since the mid 20th century, cancer drug development has been guided by the assumption that more is ...
Posted by Michael Wonder on 15 Feb 2023
Germany proposes to fix shortages in certain medicines
15 February 2023 - Germany's health ministry on Tuesday vowed to fix shortages in medicines for children, antibiotics and cancer ...
Posted by Michael Wonder on 15 Feb 2023
Transferable exclusivity voucher: a flawed incentive to stimulate antibiotic innovation
9 February 2023 - As antibiotic resistance increases globally, antibiotic innovation is struggling. The WHO states that the antibiotic clinical pipeline ...
Posted by Michael Wonder on 15 Feb 2023
The PBM Transparency Act will not lower drug prices
15 February 2023 - While members of Congress agree on the need to try to rein in the prices of prescription ...
Posted by Michael Wonder on 15 Feb 2023
FDA gene therapy head raises concern on accelerated approval use
14 February 2023 - More than 1,000 cell and gene therapy clinical trials registered. ...
Posted by Michael Wonder on 15 Feb 2023
Galera announces FDA acceptance and priority review of avasopasem NDA for radiotherapy induced severe oral mucositis
15 February 2023 - PDUFA target date of 9 August 2023. ...
Posted by Michael Wonder on 15 Feb 2023
Henlius announces US FDA acceptance of biologics license application for proposed biosimilar trastuzumab HLX02
14 February 2023 - The first Chinese biosimilar approved in both China and the EU, and potentially to be approved in ...
Posted by Michael Wonder on 15 Feb 2023
Kinnate Biopharma receives fast track designation from the US FDA for KIN-3248, an investigational pan FGFR inhibitor
14 February 2023 - Kinnate Biopharma today announced that the US FDA has granted fast track designation for Kinnate’s investigational ...
Posted by Michael Wonder on 15 Feb 2023
Vutrisiran for the treatment of patients with hereditary transthyretin-related amyloidosis
15 February 2023 - NICE has published final draft guidance on the use of vutrisiran for the treatment of adults ...
Posted by Michael Wonder on 14 Feb 2023
HHS Secretary responds to the President’s Executive Order on drug prices
14 February 2023 - Action announces new models and supports access to $2 generic drugs. ...
Posted by Michael Wonder on 14 Feb 2023
NATCO files generic olaparib tablets in US
13 February 2023 - NATCO Pharma announces submission of abbreviated new drug application containing a paragraph IV certification with the ...
Posted by Michael Wonder on 14 Feb 2023
The future of voice technologies in health care
13 February 2023 - Adam Smith believed that the division of labor is the key to growth. ...
Posted by Michael Wonder on 14 Feb 2023
Verve Therapeutics announces VERVE-101 awarded Innovation Passport by the UK MHRA for the treatment of heterozygous familial hypercholesterolaemia
14 February 2023 - Verve Therapeutics today announced that VERVE-101 has been awarded the Innovation Passport for the treatment of ...