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Results For "Advisory-Committee-on-Immunization-Practices"

8 News Found

Moderna update on investigational RSV vaccine
Drug Approval | May 14, 2024

Moderna update on investigational RSV vaccine

U.S. FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of May 12, 2024


Moderna posts Q4 2023 revenue at US$ 2.8 billion
News | February 23, 2024

Moderna posts Q4 2023 revenue at US$ 2.8 billion

Net product sales in the fourth quarter of 2023 include the recognition of $0.6 billion from deferred revenue, related to Gavi, the Vaccine Alliance


FDA approves only vaccine Penbraya for treatment of meningococcal disease in adolescents
Drug Approval | October 21, 2023

FDA approves only vaccine Penbraya for treatment of meningococcal disease in adolescents

The vaccine further advances Pfizer’s vaccine portfolio and builds on more than 20 years of expertise and knowledge in the prevention of meningococcal disease


European Commission authorises GSK’s Arexvy for older adults
Drug Approval | June 08, 2023

European Commission authorises GSK’s Arexvy for older adults

Authorisation will help protect adults 60 years of age and older in 30 European countries* from RSV disease for the first time


USFDA approves GSK’s respiratory syncytial virus vaccine ‘Arexvy’
Drug Approval | May 12, 2023

USFDA approves GSK’s respiratory syncytial virus vaccine ‘Arexvy’

Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time


USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
Drug Approval | February 22, 2023

USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency


USFDA grants emergency use authorization for Novavax COVID-19 vaccine
Drug Approval | August 22, 2022

USFDA grants emergency use authorization for Novavax COVID-19 vaccine

Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.


Sanofi flu vaccines licensed and approved for 2022-2023 influenza season
Drug Approval | July 05, 2022

Sanofi flu vaccines licensed and approved for 2022-2023 influenza season

Sanofi will begin to ship their vaccines helping to ensure more people will be immunized