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 02 Dec 2020
TG Therapeutics initiates rolling submission of biologics license application to U.S. FDA for ublituximab in combination with umbralisib as a treatment for patients with chronic lymphocytic leukaemia
1 December 2020 - Completion of rolling submission for the BLA expected in 1H21. ...
Posted by Michael Wonder on 02 Dec 2020
Britain becomes the first country to license a fully tested COVID-19 vaccine
1 December 2020 - Inoculations with the Pfizer-BioNTech jab could start in less than a week. ...
Posted by Michael Wonder on 02 Dec 2020
UK approves Pfizer/BioNTech’s COVID-19 vaccine
2 November 2020 - The UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) has authorised Pfizer/BioNTech’s COVID-19 vaccine BNT162b2 for ...
Posted by Michael Wonder on 01 Dec 2020
Ipsen receives FDA fast track designation for investigational irinotecan liposome injection (Onivyde) as a second-line monotherapy treatment for small cell lung cancer
30 November 2020 - Ipsen today announced the United States FDA has granted the company fast track designation for irinotecan liposome ...
Posted by Michael Wonder on 01 Dec 2020
VBI Vaccines announces submission of biologics license application to FDA for 3 antigen prophylactic hepatitis B vaccine
1 December 2020 - VBI Vaccines today announced the submission of a biologics license application to the U.S. FDA seeking approval ...
Posted by Michael Wonder on 01 Dec 2020
EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S
1 December 2020 - EMA’s CHMP has started a rolling review of Ad26.COV2.S, a COVID-19 vaccine from Janssen-Cilag. ...
Posted by Michael Wonder on 01 Dec 2020
Genentech announces FDA approval of Xolair (omalizumab) for adults with nasal polyps
1 December 2020 - Xolair is the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E, ...
Posted by Michael Wonder on 01 Dec 2020
Australia's 10 most commonly prescribed medicines revealed by PBS data
1 December 2020 - Australians continue to use statins more than any other prescription drug, with the two most common ...
Posted by Michael Wonder on 01 Dec 2020
Outraged patients to present petition with over 30,000 signatures to ask for funding for desperately needed medication
2 December 2020 - Sick of waiting for years for PHARMAC to fund standard, current therapy to treat their diseases, ...
Posted by Michael Wonder on 01 Dec 2020
US hopeful of pre-Christmas COVID jab, Australia still has long wait
1 December 2020 - Millions of vulnerable Americans could be vaccinated against coronavirus before the end of 2020 but it ...
Posted by Michael Wonder on 01 Dec 2020
FDA approves pralsetinib for RET altered thyroid cancers
1 December 2020 - Today the Food and Drug Administration approved pralsetinib (Gavreto, Blueprint Medicines) for adult and pediatric patients ...
Posted by Michael Wonder on 01 Dec 2020
EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2
1 December 2020 - EMA has received an application for conditional marketing authorisation for BNT162b2, a COVID‑19 mRNA vaccine developed by ...
Posted by Michael Wonder on 01 Dec 2020
FDA approves first PSMA-targeted PET imaging drug for men with prostate cancer
1 December 2020 - Today, the U.S. FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for ...
Posted by Michael Wonder on 01 Dec 2020
EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine
1 December 2020 - EMA has received an application for conditional marketing authorisation for a COVID-19 mRNA vaccine by Moderna Biotech. ...
Posted by Michael Wonder on 01 Dec 2020
Innovative technology to detect abnormal heart rhythms recommended by NICE for NHS use while further data is collected
1 December 2020 - Zio ZT is the first assessment, via the NICE digital health technologies guidance development pilot project, to ...