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RSS FeedPosted by Michael Wonder on 21 Oct 2021
FDA takes additional actions on the use of a booster dose for COVID-19 vaccines
20 October 2021 - Today, the U.S. FDA took action to expand the use of a booster dose for COVID-19 vaccines ...
Posted by Michael Wonder on 19 Oct 2021
FDA to allow ‘mix and match’ approach for Covid booster shots
18 October 2021 - The agency may act this week, when it is expected to authorise booster shots for recipients of ...
Posted by Michael Wonder on 18 Oct 2021
On COVID-19 booster shots, the FDA has overstepped its role
18 October 2021 - Booster shots for all adults six months after being vaccinated against COVID-19 are safe, effective, and ...
Posted by Michael Wonder on 14 Oct 2021
FDA accepts Regen-Cov (casirivimab and imdevimab) for priority review for treatment and prophylaxis of COVID-19
14 October 2021 - European Medicines Agency also announced earlier this week it would review marketing authorisation application for the antibody ...
Posted by Michael Wonder on 11 Oct 2021
Merck and Ridgeback announce submission of emergency use authorisation application to the U.S. FDA for molnupiravir, an investigational oral anti-viral medicine, for the treatment of mild to moderate COVID-19 in at risk adults
11 October 2021 - Submissions to regulatory agencies worldwide underway. ...
Posted by Michael Wonder on 10 Oct 2021
Brii Bio initiates submission of emergency use authorisation filing to U.S. FDA for BRII-196/BRII-198, its monoclonal antibody combination therapy for non-hospitalised COVID-19 patients at high risk of clinical progression to severe disease
8 October 2021 - Data supporting the EUA filing will be submitted to the FDA on a rolling basis with the ...
Posted by Michael Wonder on 07 Oct 2021
Pfizer seeks US authorisation of Covid-19 vaccine for ages 5-11
8 October 2021 - The Pfizer vaccine could soon be available for children as young as five in the United States. ...
Posted by Michael Wonder on 06 Oct 2021
Johnson & Johnson announces submission of emergency use authorisation amendment to the U.S. FDA to support booster of its single shot COVID-19 vaccine
5 October 2021 - Submission includes data showing a booster increased protection to 94% against moderate to severe/critical COVID-19 in the ...
Posted by Michael Wonder on 05 Oct 2021
AZD7442 request for emergency use authorisation for COVID-19 prophylaxis filed in US
5 October 2021 - Filing includes data from PROVENT Phase 3 trial showing 77% reduction in risk of developing symptomatic COVID-19 ...
Posted by Michael Wonder on 28 Sep 2021
Pfizer and BionNTech submit initial data to U.S. FDA from pivotal trial of COVID-19 vaccine in children 5 to <12 years of age
28 September 2021 - Formal submission to request Emergency Use Authorization to follow in the coming weeks. ...
Posted by Michael Wonder on 23 Sep 2021
FDA authorises booster dose of Pfizer-BioNTech COVID-19 vaccine for certain populations
22 September 2021 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 vaccine to allow ...
Posted by Michael Wonder on 18 Sep 2021
FDA advisory committee votes unanimously in favour of Comirnaty booster for emergency use in people 65 and older and certain high risk population
17 September 2021 - Committee reviewed clinical data showing a booster dose of Comirnaty elicits high neutralisation titres against SARS-CoV-2 and ...
Posted by Michael Wonder on 16 Sep 2021
Emergency use authorisation for Lilly's bamlanivimab and etesevimab administered together expanded to include post-exposure prophylaxis for COVID-19
16 September 2021 - Expanded emergency use authorisation includes certain people who have been exposed to someone infected with SARS-CoV-2 ...
Posted by Michael Wonder on 02 Sep 2021
FDA to hold Advisory Committee meeting to discuss Pfizer-BioNTech’s application for COVID-19 booster
2 September 2021 - Today, the U.S. FDA announced a virtual meeting of its Vaccines and Related Biological Products Advisory ...
Posted by Michael Wonder on 02 Sep 2021
Moderna announces submission of initial data to US FDA for its COVID-19 vaccine booster
1 September 2021 - mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40x against the ...