Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 07 Nov 2021
Ocugen announces submission of emergency use authorisation request to the US FDA for investigational COVID-19 vaccine Covaxin (BBV152) for children ages 2-18 years
5 November 2021 - Paediatric EUA submission based on immuno-bridging clinical trial in children, ages 2-18, demonstrating comparable neutralising antibody response ...
Posted by Michael Wonder on 02 Nov 2021
Moderna provides update on timing of U.S. emergency use authorisation of its COVID-19 vaccine for adolescents
31 October 2021 - Moderna today provided an update that the U.S. FDA has notified the Company that it will ...
Posted by Michael Wonder on 31 Oct 2021
FDA authorises Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 through 11 years of age
29 October 2021 - Today, the U.S. FDA authorised the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of ...
Posted by Michael Wonder on 21 Oct 2021
FDA takes additional actions on the use of a booster dose for COVID-19 vaccines
20 October 2021 - Today, the U.S. FDA took action to expand the use of a booster dose for COVID-19 vaccines ...
Posted by Michael Wonder on 19 Oct 2021
FDA to allow ‘mix and match’ approach for Covid booster shots
18 October 2021 - The agency may act this week, when it is expected to authorise booster shots for recipients of ...
Posted by Michael Wonder on 18 Oct 2021
On COVID-19 booster shots, the FDA has overstepped its role
18 October 2021 - Booster shots for all adults six months after being vaccinated against COVID-19 are safe, effective, and ...