Research led by the Veterans Affairs Portland Health Care System in Portland, Oregon, found that a single dose of respiratory ...
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) ...
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 ...
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 ...
GSK's Q3 2023 financials show strong performance, driven by Arexvy's sales; vigilance on broader market movements needed. Solid financials with improved FY guidance; liquidity constraints exist with a ...
Five months after becoming the first company to secure FDA approval for a respiratory syncytial virus (RSV) vaccine, GSK is taking steps toward expanding its label for Arexvy. On Wednesday, 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 ...
(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 ...
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 ...
PHILADELPHIA--(BUSINESS WIRE)-- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has accepted under Priority Review an application to extend the indication of GSK ...
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 ...