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RSS FeedPosted by Michael Wonder on 02 Mar 2022
Pfizer granted FDA breakthrough therapy designation for respiratory syncytial virus (RSV) vaccine candidate for the prevention of RSV in infants from birth up to six months of age by active immunisation of pregnant women
2 March 2022 - Pfizer today announced that its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, received breakthrough ...
Posted by Michael Wonder on 19 Feb 2022
FDA eyes second COVID-19 booster shot
19 February 2022 - The agency has begun reviewing data that could lead to clearing a second booster dose of ...
Posted by Michael Wonder on 14 Feb 2022
Bavarian Nordic announces breakthrough therapy designation for its RSV vaccine candidate for the prevention of respiratory syncytial virus in older adults
14 February 2022 - Bavarian Nordic announced today that the U.S. FDA has granted breakthrough therapy designation for the Company's vaccine ...
Posted by Michael Wonder on 12 Feb 2022
Pfizer and BioNTech provide update on rolling submission for emergency use authorisation of their COVID-19 vaccine in children 6 months through 4 years of age
11 February 2022 - Pfizer and BioNTech today announced plans to extend their rolling submission to the U.S. FDA seeking ...
Posted 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
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 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 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 grants ILiAD Biotechnologies fast track designation for next generation pertussis vaccine BPZE1
3 January 2021 - ILiAD Biotechnologies, today announced that the U.S. FDA has granted fast track designation to BPZE1, a next ...
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 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 ...