GSK plc

GSK

GB00BN7SWP63

Pharmaceuticals

Market Closed - London S.E. Other stock markets 11:35:01 2026-03-06 EST			5-day change	1st Jan Change
2,038.00 ^GBX	-1.83%		-5.95%	+11.70%

03-05	Illumina, Inc. and Nashville Biosciences, LLC Announce New Proteomics Data Offering and Expansion of Alliance for Genomic Discovery Dataset	CI
03-05	GSK outgoing CEO Emma Walmsley's 2025 total remuneration was 15.7 mln pounds vs 10.6 mln pounds in 2024 - annual report	RE

GSK: seeks FDA approval to expand Arexvy indication

Published on 07/14/2025 at 04:43 am EDT

GSK PLC

-1.83%

GSK announces that the FDA has agreed to review its application to expand the indication for Arexvy, its vaccine against respiratory syncytial virus (RSV), to adults aged 18 to 49 years at increased risk.

This vaccine is currently approved in the United States to prevent lower respiratory tract infections caused by RSV in adults aged 60 and older, as well as in adults aged 50 to 59 who are at high risk.

This submission is based on a Phase IIIb study showing an immune response and safety profile comparable to those seen in older adults. GSK notes that a regulatory decision from the FDA is expected in H1 2026.

In addition, the group is continuing its efforts to expand the indications for Arexvy in other regions, including Europe and Japan.

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Latest news about GSK plc

03-05	Illumina, Inc. and Nashville Biosciences, LLC Announce New Proteomics Data Offering and Expansion of Alliance for Genomic Discovery Dataset	CI
03-05	GSK outgoing CEO Emma Walmsley's 2025 total remuneration was 15.7 mln pounds vs 10.6 mln pounds in 2024 - annual report	RE
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Company Profile

GSK plc is a global biopharma company. The Companyâ€™s segments include Commercial Operations and Research and Development. It develops cancer medicines for patients, including ovarian cancer, endometrial cancer, and multiple myeloma. Its product areas include vaccines, specialty medicines, and general medicine. It is also focused on addressing the unmet treatment needs of patients with respiratory and inflammatory conditions. Its vaccine portfolio includes over 20 vaccines that help to protect people from a range of diseases and infections, including meningitis, shingles and flu, among others. Its specialty medicines are also engaged in developing medicines for respiratory disease and HIV. Its general medicines include inhaled medicines for asthma and chronic obstructive pulmonary disease, antibiotics, and medicines for skin diseases. It is advancing oligonucleotide therapeutics in chronic hepatitis B and steatotic liver disease as well as other therapeutic areas beyond liver disease.

Employees

68,629

Sector

Pharmaceuticals

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