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RSS FeedPosted 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 20 Sep 2023
Access to COVID-19 anti-viral treatments widened for more people at risk
20 September 2023 - PHARMAC is widening access to COVID-19 anti-virals to people who are vulnerable to severe infection from ...
Posted by Michael Wonder on 19 Sep 2023
MHRA approves Moderna’s adapted COVID-19 vaccine (Spikevax) that targets Omicron XBB.1.5
15 September 2023 - The vaccine was approved after it was found to meet the MHRA’s standards of safety, quality and ...
Posted by Michael Wonder on 18 Sep 2023
COVID-19 vaccine contract summary
18 September 2023 - The Ministry of Health has released a summary of the New Zealand Government’s procurement process 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 08 Sep 2023
Omicron XBB.1.5 adapted COVID-19 vaccine (DS-5670) supplemental new drug application submitted in Japan
7 September 2023 - – Daiichi Sankyo today announced that it has submitted a supplemental New Drug Application to Japan’s ...
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
MHRA approves Pfizer/BioNTech’s adapted COVID-19 vaccine (Comirnaty) that targets Omicron XBB.1.5
5 September 2023 - Approval has today been granted by the MHRA for an adapted Pfizer/BioNTech COVID-19 vaccine that targets ...
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. ...