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RSS FeedPosted by Michael Wonder on 14 Jan 2022
GSK and Vir submit emergency use authorisation application to FDA for intramuscular administration of sotrovimab for the early treatment of COVID-19
13 January 2022 - Submission follows COMET-TAIL Phase 3 data demonstrating that intramuscular administration of sotrovimab was non-inferior and offered ...
Posted by Michael Wonder on 08 Jan 2022
FDA shortens interval for booster dose of Moderna COVID-19 Vaccine to five months
7 January 2022 - Today, the U.S. FDA amended the emergency use authorisation for the Moderna COVID-19 Vaccine to shorten the ...
Posted by Michael Wonder on 04 Jan 2022
Novavax submits final data packages to U.S. FDA as prerequisite to Emergency Use Authorisation application request for COVID-19 Vaccine
30 December 2021 - EUA application request to be submitted following one month required by FDA EUA guidance. ...
Posted by Michael Wonder on 03 Jan 2022
FDA takes multiple actions to expand use of Pfizer-BioNTech COVID-19 Vaccine
3 January 2021 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 Vaccine to: ...
Posted by Michael Wonder on 23 Dec 2021
FDA authorises first oral antiviral for treatment of COVID-19
22 December 2021 - Today, the U.S. FDA issued an emergency use authorisation for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, ...
Posted by Michael Wonder on 23 Dec 2021
FDA authorises additional oral antiviral for treatment of COVID-19 in certain adults
23 December 2021 - Today, the U.S. FDA issued an emergency use authorisation for Merck’s molnupiravir for the treatment of mild-to-moderate ...
Posted by Michael Wonder on 18 Dec 2021
Pfizer and BioNTech submit supplemental biologics license application for U.S. FDA approval of Comirnaty in adolescents 12 through 15 years of age
16 December 2021 - Pfizer and BioNTech today announced they have submitted a supplemental biologics license application to the U.S. ...
Posted by Michael Wonder on 09 Dec 2021
FDA expands eligibility for Pfizer-BioNTech COVID-19 booster dose to 16 and 17 year olds
9 December 2021 - 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 09 Dec 2021
FDA authorises new long-acting monoclonal antibodies for pre-exposure prevention of COVID-19 in certain individuals
8 December 2021 - Today, the U.S. FDA issued an emergency use authorization for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and ...
Posted by Michael Wonder on 08 Dec 2021
Pfizer will submit full data on Covid treatment pill to the FDA in a few days, CEO says
8 December 2021 - Pfizer CEO Albert Bourla said he’s confident the full results from the clinical trials will show that ...
Posted by Michael Wonder on 07 Dec 2021
U.S. plans to fast track revamped COVID-19 vaccines
5 December 2021 - Study from South Africa suggests the fast-spreading Omicron variant might cause less severe illness than its predecessors. ...
Posted by Michael Wonder on 04 Dec 2021
FDA expands authorisation of two monoclonal antibodies for treatment and post-exposure prevention of COVID-19 to younger paediatric patients, including newborns
3 December 2021 - Today, the U.S. FDA revised the emergency use authorisation of bamlanivimab and etesevimab (previously authorised for paediatric ...
Posted by Michael Wonder on 20 Nov 2021
Moderna announces FDA authorisation of booster dose of COVID-19 vaccine in the U.S. for adults 18 years and older
19 November 2021 - Authorisation includes the use of Moderna’s booster dose following primary vaccination with other authorised or approved ...
Posted by Michael Wonder on 16 Nov 2021
Pfizer seeks emergency use authorisation for novel COVID-19 oral antiviral candidate
16 November 2021 - If approved or authorised, Paxlovid (PF-07321332; ritonavir) would be the first oral antiviral of its kind, a ...
Posted by Michael Wonder on 10 Nov 2021
Ellume's COVID-19 home test recall most serious, FDA says
10 November 2021 - The U.S. FDA classified the recall of Ellume's over-the-counter COVID-19 home test as Class 1, the ...