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RSS FeedPosted by Michael Wonder on 06 Jun 2022
Novavax faces high stakes FDA review this week that will decide the fate of its COVID vaccine in the U.S.
6 June 2022 - If they endorse the vaccine, the FDA will almost certainly authorise the shot for adults in the ...
Posted by Michael Wonder on 02 Jun 2022
Pfizer asks FDA to authorise COVID-19 vaccine for youngest kids
1 June 2022 - Pfizer and BioNTech announced Wednesday that they have completed their submission requesting emergency use authorisation from ...
Posted by Michael Wonder on 30 May 2022
Why won’t the FDA let doctors prescribe fluvoxamine for COVID?
30 May 2022 - Trials show it keeps patients from getting sicker, but the agency won’t approve its emergency use. ...
Posted by Michael Wonder on 17 May 2022
FDA expands eligibility for Pfizer-BioNTech COVID-19 vaccine booster dose to children 5 through 11 years
17 May 2022 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 vaccine, authorising the use ...
Posted by Michael Wonder on 17 May 2022
FDA authorises first COVID-19 test available without a prescription that also detects influenza and RSV
16 May 2022 - The EUA authorises at home sample collection with testing performed in a laboratory. ...
Posted by Michael Wonder on 16 May 2022
FDA rejects anti-depressant seen as possible COVID-19 treatment
16 May 2022 - The FDA declined Monday to authorise a 30 year old generic anti-depressant as a treatment for ...
Posted by Michael Wonder on 12 May 2022
Moderna completes FDA submission for use of COVID shot in adolescents, kids
11 May 2022 - Moderna has made all necessary submissions required by the U.S. FDA for emergency use authorisation of ...
Posted by Michael Wonder on 10 May 2022
FDA approves treatment for COVID-19 in certain hospitalised adults
10 May 2022 - Today, the FDA approved a new indication for Olumiant (baricitinib) for the treatment of COVID-19 in hospitalised ...
Posted by Michael Wonder on 07 May 2022
FDA limits use of Janssen COVID-19 vaccine to certain individuals
5 May 2022 - Today, the U.S. FDA has limited the authorised use of the Janssen COVID-19 Vaccine to individuals ...
Posted by Michael Wonder on 29 Apr 2022
Moderna files for authorisation of its COVID-19 vaccine in young children six months to under six years of age
28 April 2022 - Submission to regulators globally is based on Phase 2/3 studies of mRNA-1273 in young children. ...
Posted by Michael Wonder on 27 Apr 2022
Pfizer and BioNTech submit application for U.S. emergency use authorisation for a COVID-19 vaccine booster dose in children 5 through 11 years of age
26 April 2022 - Pfizer and BioNTech today submitted an application to the U.S. Food and Drug Administration (FDA) for ...
Posted by Michael Wonder on 25 Apr 2022
FDA approves first COVID-19 treatment for young children
25 April 2022 - Today, the US FDA expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include paediatric ...
Posted by Michael Wonder on 06 Apr 2022
Some hoped FDA approval of Pfizer's COVID vaccine would convince unvaccinated Americans. It didn't, study finds.
6 April 2022 - After the Food and Drug Administration approved Pfizer-BioNTech’s COVID-19 vaccine in August, public health experts were ...
Posted by Michael Wonder on 06 Apr 2022
U.S. FDA aims to decide on strain selection for COVID boosters by June
6 April 2022 - The U.S. FDA said it is aiming to come up with a decision on coronavirus strain ...
Posted by Michael Wonder on 05 Apr 2022
FDA updates sotrovimab emergency use authorisation
5 April 2022 - Sotrovimab is no longer authorised to treat COVID-19 in any U.S. region due to increases in ...