US FDA approves GSK’s AREXVY, the world’s first respiratory …
WEBMay 3, 2023 · Respiratory syncytial virus vaccine, adjuvanted, contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01 E adjuvant. In the US, AREXVY is indicated for the prevention of RSV-LRTD in individuals 60 years of age and older.
GSK's Respiratory Syncytial Virus Vaccine Given Together With …
WEB2 days ago · Wednesday, GSK plc (NYSE:GSK) released topline data from the phase 3 trial in adults 50 years and older evaluating the immunogenicity, reactogenicity and safety of Arexvy (Respiratory Syncytial ...
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.
New data for AREXVY, GSK’s RSV vaccine, show potential to help …
WEBOct 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 approves first vaccine for RSV, a moment six decades in the ... - CNN
WEBMay 3, 2023 · CNN — After a 60-year scientific quest, the world has its first vaccine to protect against respiratory syncytial virus, or RSV – and more are on the way. On Wednesday, the US Food and Drug...
GSK Announces Positive Topline Data on Co-Administration of
WEB3 days ago · The Control group received GSK’s RSV vaccine at day 31. 1,2 RZV second dose was administered at day 61 for both groups. 1,2 The primary endpoint was the non-inferiority of the humoral immune responses to GSK’s RSV vaccine and RZV when co-administered compared to when administered at separate visits. 1,2 Key secondary endpoints included ...
FDA advisers recommend world's first RSV vaccines, from Pfizer and GSK
WEBMar 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.
About Arexvy (respiratory syncytial virus vaccine, adjuvanted) - GSK
WEBJun 21, 2023 · GSK plc (LSE/NYSE: GSK) today announced new data from the AReSVi-006 (A dult R espiratory S yncytial V irus) phase III trial evaluating the efficacy of a single dose of Arexvy (respiratory syncytial virus vaccine, adjuvanted) against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in …
About Arexvy (Respiratory Syncytial Virus (RSV) vaccine ... - GSK
WEBJul 10, 2023 · Arexvy (Respiratory Syncytial Virus (RSV) vaccine, (recombinant, adjuvanted)) summary of product characteristics (SmPC) July 2023. Authorisation will help protect adults 60 years of age and older in the UK from RSV disease for the first time.
GSK Meets Study Goal for Co-Administered RSV-Shingles Vaccines
WEB1 day ago · ILMN. BVS. GSK announced positive topline results from a phase III study evaluating the co-administration of its two marketed vaccines — RSV vaccine Arexvy and shingles vaccine Shingrix — in ...
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