The FDA has accepted for review the sBLA to expand the indication of Arexvy (RSV vaccine, adjuvanted) to adults aged 18 to 49 years who are at increased risk.

Guillain-Barre syndrome is a rare but serious condition which needs urgent treatment in hospital to prevent it progressing.

GSK's vaccine is currently approved in the U.S. for preventing RSV-related disease in adults aged 60 and above, and in ...

London: GSK plc has announced that the US Food and Drug Administration (FDA) has accepted for review an application to extend ...

GSK plc GSK announced that the FDA has accepted its regulatory filing seeking to expand the use of its RSV vaccine, Arexvy, in adults under 50 who are at a higher risk of the disease. A final decision ...

The Food and Drug Administration on Wednesday approved Arexvy, the world's first respiratory syncytial virus (RSV) vaccine — a scientific breakthrough 60 years in the making.

Arexvy is an adjuvanted vaccine, meaning that it combines its immunogen mimicking part of the virus with an additional ingredient to trigger stronger immune responses.

AREXVY is not approved for use in persons <50 years of age Vaccination with AREXVY may not result in protection of all vaccine recipients Please see full Prescribing Information for AREXVY.

Arexvy is just the first downstream result of this discovery to be approved by the FDA, and more will likely follow soon. Pfizer’s RSV vaccine for adults will probably be approved later this ...

Arexvy dominates U.S. retail vaccine market in Q3; management optimistic but mindful of competitive landscape. Investment recommendation: "Speculative Buy" on GSK, ...

GSK plc today announced that AREXVY is now available in the US at all major retail pharmacies. In June, the Advisory Committee on Immunization Practices recommended that persons 60 years of age ...

GSK's major growth drivers, Shingrix and Arexvy, along with recent legal progress, make its current undervaluation unjustified. See what to expect from GSK's Q3.