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RSS FeedPosted by Michael Wonder on 04 Oct 2023
FDA authorises updated Novavax COVID-19 vaccine formulated to better protect against currently circulating variants
3 October 2023 - Today, the US FDA amended the emergency use authorisation of the Novavax COVID-19 vaccine, adjuvanted for use ...
Posted by Michael Wonder on 03 Oct 2023
Swissmedic approves Moderna coronavirus vaccine Spikevax XBB.1.5
28 September 2023 - Spikevax XBB.1.5 approved for persons aged 18 and over ...
Posted by Michael Wonder on 29 Sep 2023
Pfizer and BioNTech receive Health Canada authorisation for XBB.1.5 adapted monovalent COVID-19 vaccine
28 September 2023 - The updated vaccine is expected to be available in Canada in the coming weeks. ...
Posted by Michael Wonder on 21 Sep 2023
Supply and insurance issues snarl fall COVID-19 vaccine campaign for some
20 September 2023 - It has been just over a week since the US FDA and the US Centers for ...
Posted by Michael Wonder on 14 Sep 2023
Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
14 September 2023 - EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax vaccine targeting the Omicron XBB.1.5 ...
Posted by Michael Wonder on 13 Sep 2023
Health Canada authorises Moderna COVID-19 vaccine targeting the Omicron XBB.1.5 sub-variant
12 September 2023 - Health Canada has authorised the use of the Moderna Spikevax COVID-19 vaccine targeting the Omicron XBB.1.5 ...
Posted by Michael Wonder on 11 Sep 2023
FDA takes action on updated mRNA COVID-19 vaccines to better protect against currently circulating variants
11 September 2023 - Today, the US FDA took action approving and authorising for emergency use updated COVID-19 vaccines formulated to ...
Posted by Michael Wonder on 07 Sep 2023
FDA may approve new Covid boosters by Friday as deaths spike
6 September 2023 - The FDA could approve new Covid-19 vaccine boosters as soon as Friday, NBC reported Wednesday, offering more ...
Posted by Michael Wonder on 06 Sep 2023
Arcturus Therapeutics and CSL announce European Medicines Agency validates marketing authorisation application for ARCT-154 vaccine to prevent COVID-19
5 September 2023 - EMA application supported by Phase 3 primary vaccination study demonstrating primary efficacy endpoint was met. ...
Posted by Michael Wonder on 05 Sep 2023
SK Bioscience withdraws conditional marketing authorisation for COVID-19 vaccine in EU
4 September 2023 - SK Bioscience said it has voluntarily withdrawn its application for a conditional marketing authorisation license to ...
Posted by Michael Wonder on 02 Sep 2023
Additional COVID-19 vaccine dose recommended for adults 75 years and over
1 September 2023 - The Australian Government has accepted advice from the Australian Technical Advisory Group on Immunisation (ATAGI) that all ...
Posted by Michael Wonder on 31 Aug 2023
InflaRx’s marketing authorisation application for vilobelimab for treatment of critically ill COVID-19 patients under review by European Medicines Agency
30 August 2023 - Regulatory submission based on pivotal data from PANAMO Phase III trial. ...
Posted by Michael Wonder on 30 Aug 2023
EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
30 August 2023 - The EMA’s CHMP has recommended authorising an adapted Comirnaty vaccine targeting the Omicron XBB.1.5 subvariant. ...
Posted by Michael Wonder on 10 Aug 2023
New COVID-19 vaccine and booster shots for this fall to be available by end of September
9 August 2023 - The first new COVID-19 vaccines updated for this fall season are now expected to be available by ...
Posted by Michael Wonder on 07 Jul 2023
Phasing out of extraordinary COVID-19 regulatory flexibilities
6 July 2023 - EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the ...