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RSS FeedPosted by Michael Wonder on 01 Feb 2022
Pfizer and BioNTech initiate rolling submission for emergency use authorisation of their COVID-19 vaccine in children 6 months through 4 years of age following request from U.S. FDA
1 February 2022 - Companies plan to submit additional data on a third 3 µg dose in this age group in ...
Posted by Michael Wonder on 01 Feb 2022
Veru announces FDA grant of fast track designation for sabizabulin for the treatment of hospitalised COVID-19 patients at high risk for acute respiratory distress syndrome
31 January 2022 - Second Veru drug under development to receive FDA fast track designation this month. ...
Posted by Michael Wonder on 01 Feb 2022
Novavax submits request to the U.S. FDA for emergency use authorisation of COVID-19 Vaccine
31 January 2022 - NVX-CoV2373 demonstrated overall efficacy of ~90% in PREVENT-19 clinical trial conducted during the emergence of variant ...
Posted by Michael Wonder on 31 Jan 2022
Coronavirus (COVID-19) update: FDA takes key action by approving second COVID-19 vaccine
31 January 2022 - Today, the U.S. FDA approved a second COVID-19 vaccine. ...
Posted by Michael Wonder on 26 Jan 2022
Pfizer pushes to intervene in lawsuit seeking COVID vaccine information from FDA
27 January 2022 - Pfizer wants to intervene in a Texas federal lawsuit seeking information from the U.S. FDA used ...
Posted by Michael Wonder on 24 Jan 2022
FDA considers limiting authorisation of certain monoclonal antibody treatments
23 January 2022 - Federal regulators are considering limiting the authorisation of certain monoclonal antibody treatments that have not proved ...
Posted by Michael Wonder on 22 Jan 2022
COVID-19 vaccines and treatments: we must have raw data, now
19 January 2022 - Data should be fully and immediately available for public scrutiny ...
Posted by Michael Wonder on 22 Jan 2022
FDA takes actions to expand use of treatment for outpatients with mild to moderate COVID-19
21 January 2022 - Today, the U.S. FDA took two actions to expand the use of the antiviral drug Veklury (remdesivir) ...
Posted 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. ...