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RSS FeedPosted 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4 September 2023 - SK Bioscience said it has voluntarily withdrawn its application for a conditional marketing authorisation license to ...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. ...
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 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 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 01 Aug 2023
PHARMAC considers access criteria for COVID-19 anti-viral treatments
1 August 2023 - PHARMAC is consulting on changes to the access criteria for all COVID-19 anti-viral treatments to include ...
Posted by Michael Wonder on 27 Jul 2023
Molnupiravir will remain available for people who need it
27 July 2023 - PHARMAC has confirmed today that molnupiravir will remain available as a treatment to protect against infection ...