An expert panel of the European Medicines Agency (EMA) has endorsed expanding the marketing authorization for Arexvy, a ...

GSK said on Friday a panel of the European Medicines Agency had backed the use of its respiratory syncytial virus (RSV) ...

Arexvy is GSK’s adjuvanted recombinant vaccine designed to prevent lower respiratory tract disease (LRTD) caused by RSV. Initially approved for adults aged 60 and older, as well as those aged 50-59 ...

The recommendation by the CHMP should now result in approval of Arexvy in the broader age range in February next year, and ...

GSK said on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use had recommended ...

GSK announced that Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) is now available in the United States at all major retail pharmacies. In June, the Advisory Committee on Immunization ...

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) ...

Investing.com -- GSK plc (LSE:GSK) announced Friday that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the indication of its RSV ...

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 ...

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 ...

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 ...