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RSS FeedPosted 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 04 Sep 2023
Working with Te Whatu Ora to enable better access to vaccines
4 September 2023 - This year, many New Zealanders received their vaccinations at pharmacies close to their homes or workplaces. ...
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 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 29 Aug 2023
Health Canada accepts Valneva’s Chikungunya vaccine license application for review
29 August 2023 - Valneva today announced that Health Canada has completed screening validation of the Company’s regulatory application for ...
Posted by Michael Wonder on 25 Aug 2023
European Commission approves Pfizer’s Abrysvo to help protect infants through maternal immunisation and older adults from RSV
24 August 2023 - Abrysvo is the first and only RSV vaccine approved in the European Union for both older ...
Posted by Michael Wonder on 22 Aug 2023
CDC, pharmacies try to speed up Covid vaccine program for the uninsured
21 August 2023 - The timing gap prompted concerns from public health experts, who fear that it would further complicate the ...
Posted by Michael Wonder on 21 Aug 2023
FDA approves first vaccine for pregnant individuals to prevent RSV in infants
21 August 2023 - Today, the US FDA approved Abrysvo (respiratory syncytial virus vaccine), the first vaccine approved for use in ...
Posted by Michael Wonder on 16 Aug 2023
PHARMAC calls for applications from the suppliers of vaccines that protect against COVID-19
16 August 2023 - PHARMAC is interested to hear from pharmaceutical suppliers who manufacture vaccines that protect against COVID-19 and ...
Posted by Michael Wonder on 14 Aug 2023
Valneva announces PDUFA date extension for Chikungunya virus vaccine candidate
14 August 2023 – Valneva today announced that the US FDA has revised the PDUFA action date for the biologics ...
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 08 Aug 2023
UKHSA unveils VDEC in ‘step change’ for UK’s growing vaccine capabilities
7 August 2023 - Vaccine Development and Evaluation Centre to be at forefront of UK’s ability to research and develop vaccines ...