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.

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

GSK announces US FDA accepts application to review expanded use of RSV vaccine, Arexvy for adults 18-49 at increased risk: London, UK Wednesday, July 16, 2025, 14:00 Hrs [IST] GSK ...

The label expansion sought by GSK is a bid to compete with Pfizer and Moderna in the younger age groups of the RSV vaccine market. Pfizer’s Abrysvo and Moderna’s mRESVIA are both approved to prevent ...

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

The UK's medicines regulator has warned NHS healthcare staff about an increased risk of a condition affecting the nerves in ...

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

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

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 ...

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.