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RSS FeedPosted by Michael Wonder on 06 Jun 2022
Novavax faces high stakes FDA review this week that will decide the fate of its COVID vaccine in the U.S.
6 June 2022 - If they endorse the vaccine, the FDA will almost certainly authorise the shot for adults in the ...
Posted by Michael Wonder on 06 Jun 2022
GSK announces US FDA approval of Priorix for the prevention of measles, mumps and rubella in individuals 12 months of age and older
6 June 2022 - Priorix becomes an additional source of measles, mumps and rubella vaccine for US patients ...
Posted by Michael Wonder on 02 Jun 2022
Pfizer asks FDA to authorise COVID-19 vaccine for youngest kids
1 June 2022 - Pfizer and BioNTech announced Wednesday that they have completed their submission requesting emergency use authorisation from ...
Posted by Michael Wonder on 24 May 2022
Blue Lake Biotechnology announces FDA fast track designation for BLB-201 intranasal RSV vaccine
24 May 2022 - Blue Lake Biotechnology today announced that the U.S. FDA has granted fast track designation for BLB-201, an ...
Posted by Michael Wonder on 17 May 2022
FDA expands eligibility for Pfizer-BioNTech COVID-19 vaccine booster dose to children 5 through 11 years
17 May 2022 - 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 12 May 2022
Moderna completes FDA submission for use of COVID shot in adolescents, kids
11 May 2022 - Moderna has made all necessary submissions required by the U.S. FDA for emergency use authorisation of ...
Posted by Michael Wonder on 07 May 2022
FDA limits use of Janssen COVID-19 vaccine to certain individuals
5 May 2022 - Today, the U.S. FDA has limited the authorised use of the Janssen COVID-19 Vaccine to individuals ...
Posted by Michael Wonder on 29 Apr 2022
Moderna files for authorisation of its COVID-19 vaccine in young children six months to under six years of age
28 April 2022 - Submission to regulators globally is based on Phase 2/3 studies of mRNA-1273 in young children. ...
Posted by Michael Wonder on 27 Apr 2022
Pfizer and BioNTech submit application for U.S. emergency use authorisation for a COVID-19 vaccine booster dose in children 5 through 11 years of age
26 April 2022 - Pfizer and BioNTech today submitted an application to the U.S. Food and Drug Administration (FDA) for ...
Posted by Michael Wonder on 14 Apr 2022
Merck announces US FDA has granted breakthrough therapy designation for V116, the Company’s investigational 21 valent Pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults
14 April 2022 - V116 designed to target serotypes that account for 85% of all invasive pneumococcal disease in individuals aged ...
Posted by Michael Wonder on 06 Apr 2022
Some hoped FDA approval of Pfizer's COVID vaccine would convince unvaccinated Americans. It didn't, study finds.
6 April 2022 - After the Food and Drug Administration approved Pfizer-BioNTech’s COVID-19 vaccine in August, public health experts were ...
Posted by Michael Wonder on 06 Apr 2022
U.S. FDA aims to decide on strain selection for COVID boosters by June
6 April 2022 - The U.S. FDA said it is aiming to come up with a decision on coronavirus strain ...
Posted by Michael Wonder on 04 Apr 2022
FDA shuts out its own experts in authorising another vaccine booster
3 April 2022 - Decisions like this only reinforce the perception that Covid policy is driven by groupthink and politics. ...
Posted by Michael Wonder on 01 Apr 2022
Merck provides update on FDA review of supplemental biologics license application for Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for use in infants and children
1 April 2022 - - Merck today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug ...
Posted by Michael Wonder on 29 Mar 2022
FDA authorises second booster dose of two COVID-19 vaccines for older and immunocompromised individuals
29 March 2022 - Today, the U.S. FDA authorised a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 ...