US FDA approves GSK’s AREXVY, the world’s first respiratory …
WEBMay 3, 2023 · AREXVY is the first approved RSV vaccine for older adults, expanding GSK’s industry-leading vaccine portfolio, which protects millions of people from infectious diseases each year. Our focus now is to ensure eligible older adults in the US can access the vaccine as quickly as possible and to progress regulatory review in other countries.”
GSK presents positive data for AREXVY, its respiratory syncytial virus ...
WEB2 days ago · GSK plc (LSE/NYSE: GSK) today announced new data from the AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial evaluating the efficacy and safety of a single dose of AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in …
US FDA approves expanded age indication for GSK’s AREXVY, the …
WEBJun 7, 2024 · GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved AREXVY (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk.
GSK Says RSV Vaccine Offers Protection Over Three Seasons
WEB2 days ago · 1:42. GSK Plc’s shot for respiratory syncytial virus provided protection across three seasons after vaccination, the company said Tuesday. The shot for older adults showed cumulative efficacy ...
US FDA approves GSK’s Arexvy, the world’s first respiratory …
WEBMay 3, 2023 · US FDA approves GSK’s Arexvy, the world’s first respiratory syncytial virus (RSV) vaccine for older adults. Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time. The approval is based on data from the positive pivotal AReSVi-006 phase III trial that showed exceptional efficacy ...
GSK Presents Positive Data for AREXVY, Its Respiratory Syncytial Virus ...
WEB2 days ago · Today's results indicate that after a single dose of GSK’s RSV vaccine, cumulative efficacy over three full RSV seasons was clinically meaningful at 62.9% against RSV-LRTD (97.5% CI, 46.7-74.8 ...
GSK Presents Positive Data for AREXVY, Its Respiratory Syncytial Virus ...
WEB2 days ago · Today's results indicate that after a single dose of GSK’s RSV vaccine, cumulative efficacy over three full RSV seasons was clinically meaningful at 62.9% against RSV-LRTD (97.5% CI, 46.7-74.8, 48 of 12,468 vs 215 of 12,498) and 67.4% against severe RSV-LRTD (95% CI, 42.4-82.7, 15 of 12,468 vs 75 of 12,498) compared to placebo.
‘A good day’: FDA approves world’s first RSV vaccine - Nature
WEBMay 3, 2023 · The US Food and Drug Administration (FDA) has approved GSK’s vaccine against respiratory syncytial virus (RSV) for use in people aged 60 years and older. This is the first RSV vaccine...
FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine
WEBMay 4, 2023 · Today, the U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. Arexvy is approved for the prevention...
RSV vaccines score landmark FDA approvals - Nature
WEBMay 31, 2023 · GSK’s Arexvy and Pfizer’s Abrysvo provide older adults with a much-needed vaccine for respiratory syncytial virus (RSV) — and raise hopes for an option for infants too.