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RSS FeedPosted by Michael Wonder on 23 Feb 2021
FDA to allow Pfizer-BioNTech vaccine to be stored at higher temperatures
24 February 2021 - The U.S. FDA plans to approve Pfizer Inc and BioNTech SE’s request to store their COVID-19 ...
Posted by Michael Wonder on 22 Feb 2021
FDA outlines fast path for shots against new virus variants
23 February 2021 - Variants are already causing problems for testing, treatment. ...
Posted by Michael Wonder on 21 Feb 2021
The price of success—how to evaluate COVID-19 vaccines when they’re available outside of clinical trials
20 February 2021 - In science, as in other fields of endeavour, success can have unexpected consequences. ...
Posted by Michael Wonder on 20 Feb 2021
Pfizer and BioNTech submit COVID-19 vaccine stability data at standard freezer temperature to the U.S. FDA
19 February 2021 - Pfizer and BioNTech today announced the submission of new data to the U.S. FDA demonstrating the stability ...
Posted by Michael Wonder on 18 Feb 2021
Johnson & Johnson has only a few million COVID-19 vaccine doses in stock as likely launch nears
18 February 2021 - Johnson & Johnson has only a few million doses of its experimental COVID-19 vaccine in its ...
Posted by Michael Wonder on 17 Feb 2021
COVID-19 vaccine approval process: does it take too long?
15 February 2021 - Here are answers to some questions about the FDA review panels. ...
Posted by Michael Wonder on 16 Feb 2021
The US regulatory system and COVID-19 vaccines: the importance of a strong and capable FDA
15 February 2021 - For many in public health and medicine, the coronavirus disease 2019 (COVID-19) pandemic in the US has ...
Posted by Michael Wonder on 10 Feb 2021
FDA authorises monoclonal antibodies for treatment of COVID-19
9 February 2021 - Today, the U.S. FDA issued an emergency use authorisation for bamlanivimab and etesevimab administered together for the ...
Posted by Michael Wonder on 07 Feb 2021
Novavax announces start of rolling review by multiple regulatory authorities for COVID-19 vaccine authorisation
4 February 2021 - Rolling reviews have commenced by FDA, MHRA, EMA and Health Canada. ...
Posted by Michael Wonder on 06 Feb 2021
FDA announces Advisory Committee meeting to discuss Janssen Biotech’s COVID-19 vaccine candidate
4 February 2021 - The U.S. FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on ...
Posted by Michael Wonder on 06 Feb 2021
Johnson & Johnson announces submission of application to the U.S. FDA for Emergency Use Authorisation of its investigational single shot Janssen COVID-19 vaccine candidate
4 February 2021 - Johnson & Johnson intends to distribute vaccine to the U.S. government immediately following authorisation, and expects to ...
Posted by Michael Wonder on 15 Jan 2021
Funding of pharmaceutical innovation during and after the COVID-19 pandemic
14 January 2021 - The COVID-19 pandemic has highlighted the available mechanisms for funding research, development, manufacturing, and distribution in the ...
Posted by Michael Wonder on 14 Jan 2021
Pfizer boosts its COVID-19 vaccine output by 2 billion doses
14 January 2021 - The head of pharmaceutical giant Pfizer says its has produced more of its Covid vaccine than ...
Posted by Michael Wonder on 14 Jan 2021
Innovation Pharmaceuticals’ brilacidin for the treatment of COVID-19 receives FDA fast track designation
14 January 2021 - Innovation Pharmaceuticals is pleased to announce that the U.S. FDA has designated as a fast track development ...
Posted by Michael Wonder on 08 Jan 2021
FDA statement on following the authorised dosing schedules for COVID-19 vaccines
4 January 2021 - Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 disease ...