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.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug alert for the Abrysvo (made by Pfizer) and ...

British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to extend the ...

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 ...

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

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 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'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.