US FDA approves GSK’s AREXVY, the world’s first respiratory …
May 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.
GSK presents positive data for AREXVY, its respiratory syncytial virus ...
Oct 8, 2024 · 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 adults aged 60 ...
FDA approves first vaccine for RSV, a moment six decades in the ... - CNN
May 3, 2023 · On Wednesday, the US Food and Drug Administration approved Arexvy, made by GSK, which is designed to be given as a single shot to adults 60 and older. Late-stage RSV vaccine trials show 'exciting...
New data for AREXVY, GSK’s RSV vaccine, show potential to help …
Oct 25, 2023 · New data for AREXVY, GSK’s RSV vaccine, show potential to help protect adults aged 50 to 59 at increased risk for RSV disease. Preliminary results from phase III trial show primary endpoints met, with non-inferior immune responses observed in adults aged 50-59 compared to adults aged 60 and older.
FDA advisers recommend world's first RSV vaccines, from Pfizer and GSK
Mar 1, 2023 · An FDA advisory committee has recommended that the agency approve two RSV vaccines for older people, one from Pfizer and another from GSK.
RSV vaccine: FDA approves GSK shot for older adults
May 3, 2023 · The GlaxoSmithKline shot is now the world’s first fully approved vaccine that targets respiratory syncytial virus. The FDA’s decision is a victory for GSK in a tight race against drugmakers...
About Arexvy (respiratory syncytial virus vaccine, adjuvanted) - GSK
Jun 21, 2023 · New results from the ongoing AReSVi-006 phase III trial show vaccine efficacy against RSV-lower respiratory tract disease and severe disease over two full RSV seasons, including in participants with underlying medical conditions
‘A good day’: FDA approves world’s first RSV vaccine - Nature
May 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 to...
FDA approves GSK RSV vaccine for adults 50 to 59 - CNBC
Jun 7, 2024 · FDA approves GSK’s RSV vaccine for high-risk adults ages 50 to 59, expanding shot’s reach. The Food and Drug Administration expanded the approval of GSK’s respiratory syncytial virus...
RSV vaccine race heats up with highly effective GSK shot
Oct 13, 2022 · Data unveiled on Thursday showed GSK's respiratory syncytial virus (RSV) vaccine was 82.6% effective in a keenly watched late-stage study involving older adults.