GSK (NYSE:GSK) announced Tuesday that Arexvy, a Phase 3 trial for its FDA-approved vaccine against Respiratory Syncytial Virus (RSV), generated protection against the virus over three full seasons in ...

According to GSK, an FDA approval decision is expected in the first half of 2026. The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) ...

Tony Wood, Chief Scientific Officer, GSK: “We are pleased with ACIP's recommendation to expand the benefits of RSV immunization to more than 13 million adults aged 50-59 who are at increased risk for ...

PHILADELPHIA--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) today announced new preliminary data for AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) in adults aged 18-49 at increased risk for ...

Final data from these trials will be submitted to the Food and Drug Administration to support a label expansion to include these patient populations. Preliminary data were announced from 2 clinical ...

(RTTNews) - GSK plc (GSK, GSK.L) announced Monday that its Respiratory Syncytial Virus or RSV vaccine, Arexvy, has received positive opinion from the European Medicines Agency's Committee for ...

The first respiratory syncytial virus (RSV) vaccine has been approved for adults aged 50 to 59 years who are at increased risk. The FDA has granted an expanded age indication for GSK’s Arexvy for the ...

A Prescription Drug User Fee Act target date of June 7, 2024 has been set for the application. The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics ...

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 Administration ...

The MarketWatch News Department was not involved in the creation of this content. -- Arexvy will account for the majority share of publicly funded RSV vaccine doses provided in the country for ...