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 14 Feb 2022
Axcella Therapeutics announces FDA fast track designation for AXA1125 in NASH
14 February 2022 - EMMPACT Phase 2b clinical trial enrolling well, with interim data expected in mid 2022. ...
Posted by Michael Wonder on 14 Feb 2022
US FDA grants the coveted breakthrough designation for early stage prostate cancer detection blood test developed in India by Datar Cancer Genetics
14 February 2022 - It is the first blood test able to detect early stage prostate cancer with high accuracy ...
Posted by Michael Wonder on 14 Feb 2022
Singapore is the latest country to approve Novavax’s COVID vaccine while the U.S. reviews application
14 February 2022 - On Monday, Singapore approved the COVID vaccine from U.S. vaccine maker Novavax for adults over age 18, ...
Posted by Michael Wonder on 14 Feb 2022
EMA starts safety review of Janus kinase inhibitors for inflammatory disorders
11 February 2022 - EMA’s safety committee, PRAC, has started a review of the safety of Janus kinase (JAK) inhibitors ...
Posted by Michael Wonder on 14 Feb 2022
U.S. consumer agency schedules meeting on drug prices
11 February 2022 - The U.S. Federal Trade Commission will consider at its upcoming meeting new orders for large pharmacies ...
Posted by Michael Wonder on 14 Feb 2022
Spectrum Pharmaceuticals announces acceptance of new drug application filing for poziotinib
11 February 2022 - Spectrum Pharmaceuticals today announced that its new drug application for poziotinib has been accepted for review by ...
Posted by Michael Wonder on 14 Feb 2022
PHARMAC proposing to widen access to funded medicines
14 February 2022 - PHARMAC has issued a consultation today on proposals to widen access to two medicines, rituximab and zoledronic ...
Posted by Michael Wonder on 13 Feb 2022
How is NICE supporting digital health technology developers?
10 February 2022 - From sensor-enabled glasses that facilitate self-management for major depression to devices that measure muscle performance to ...
Posted by Michael Wonder on 13 Feb 2022
The FDA and its new commissioner must follow the science
13 February 2022 - The FDA has the awesome responsibility to protect public health by ensuring the safety and effectiveness of ...
Posted by Michael Wonder on 13 Feb 2022
Novavax – first protein vaccine now available
11 February 2022 - Australia’s first protein vaccine, Novavax will join the national rollout from Monday through select general practices, community ...
Posted by Michael Wonder on 13 Feb 2022
First young children now taking life changing cystic fibrosis treatment on NHS
12 February 2022 - One of the first children to receive the game changing cystic fibrosis treatment, Kaftrio, on the ...
Posted by Michael Wonder on 12 Feb 2022
Health economic assessment of Jemperli in endometrial cancer
11 February 2022 - TLV has produced a health economic assessment for the regions for the drug Jemperli (dostarlimab) which is ...
Posted by Michael Wonder on 12 Feb 2022
Industry cites outdated standards as flaw in FDA’s real world data draft guidance
11 February 2022 - The US FDA should adopt updated data standards that accommodate the “evolving and emerging” nature of ...
Posted by Michael Wonder on 12 Feb 2022
China approves use of Pfizer's COVID drug Paxlovid
12 February 2022 - China's medical products regulator said on Saturday it has given conditional approval for Pfizer's COVID-19 drug ...
Posted by Michael Wonder on 12 Feb 2022
Pfizer and BioNTech provide update on rolling submission for emergency use authorisation of their COVID-19 vaccine in children 6 months through 4 years of age
11 February 2022 - Pfizer and BioNTech today announced plans to extend their rolling submission to the U.S. FDA seeking ...