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RSS FeedPosted by Michael Wonder on 23 Aug 2022
Veru granted expedited provisional registration regulatory pathway for sabizabulin treatment in hospitalised COVID-19 patients by Australia’s TGA
22 August 2022 - Veru today announced that Australia’s TGA has determined that sabizabulin treatment in hospitalised COVID-19 patients at ...
Posted by Michael Wonder on 22 Aug 2022
Pfizer and BioNTech submit application to U.S. FDA for emergency use authorisation of Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine
22 August 2022 - Companies have rapidly scaled production and stand ready to deliver doses of Omicron BA.4/BA.5 adapted bivalent vaccines ...
Posted by Michael Wonder on 22 Aug 2022
TGA grants provisional determination for sabizabulin for the treatment of COVID-19
22 August 2022 - On 19 August 2022, the TGA granted a provisional determination to Adjutor Healthcare for a new ...
Posted by Michael Wonder on 20 Aug 2022
Health Canada approves COVID-19 booster dose for kids 5 to 11
19 August 2022 - The 10 mcg dose can be given at least 6 months after primary series is completed. ...
Posted by Michael Wonder on 18 Aug 2022
EMA starts review of conditional marketing authorisation application for Skycovion COVID-19 vaccine
18 August 2022 - The EMA’s CHMP has started a review of a conditional marketing authorisation application for Skycovion, a ...
Posted by Michael Wonder on 15 Aug 2022
Novavax submits application to the U.S. FDA for emergency use authorisation for Novavax COVID-19 vaccine, adjuvanted as a booster in adults aged 18 and older
15 August 2022 - If authorised, Novavax' vaccine would be the first protein-based COVID-19 booster for adults. ...
Posted by Michael Wonder on 15 Aug 2022
ATAGI recommends COVID-19 vaccine use in some children aged 6 months to 4 years
12 August 2022 - From 5 September 2022, the Australian Technical Advisory Group on Immunisation recommends COVID-19 vaccination for children aged ...
Posted by Michael Wonder on 11 Aug 2022
COVID-19 vaccine safety report (11 August 2022)
11 August 2022 - To 7 August 2022, the TGA has received 665 reports which have been assessed as likely to ...
Posted by Michael Wonder on 10 Aug 2022
Failed COVIDSafe app deleted
10 August 2022 - The Albanese Government has acted to delete the wasteful and ineffective COVIDSafe app. ...
Posted by Michael Wonder on 10 Aug 2022
EU regulator begins review of Pfizer-BioNTech's variant adapted COVID shot
9 August 2022 - The EMA has started a rolling review of a variant-adapted COVID-19 vaccine from Pfizer and BioNTech, ...
Posted by Michael Wonder on 03 Aug 2022
COVID-19 vaccines undergoing evaluation (3 August 2022)
3 August 2022 - The TGA has published a list (table) of the COVID-19 vaccines currently under evaluation by the agency. ...
Posted by Michael Wonder on 03 Aug 2022
TGA commences evaluation of Pfizer's COVID-19 vaccine (Comirnaty) for children aged 6 months to less than 5 years
3 August 2022 - The TGA has commenced evaluation of an application from Pfizer to extend the use of its ...
Posted by Michael Wonder on 02 Aug 2022
SK bioscience submits application for conditional marketing authorisation of COVID-19 vaccine, SKYCovion to European Medicines Agency
1 August 2022 - SK bioscience will accelerate to apply for emergency use listing to the World Health Organization. ...
Posted by Michael Wonder on 29 Jul 2022
ATAGI update following weekly COVID-19 meeting (27 July 2022)
29 July 2022 - An update from the Australian Technical Advisory Group on Immunisation following their weekly meeting on 27 July ...
Posted by Michael Wonder on 28 Jul 2022
COVID-19 vaccine safety report (28 July 2022)
29 July 2022 - To 24 July 2022, the TGA has received 615 reports which have been assessed as likely to ...