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

FDA accepts GSK's application to expand Arexvy vaccine use to at-risk adults aged 18–49, with a decision expected in the ...

GSK said on Friday that its respiratory syncytial virus (RSV) vaccine has received approval in Japan for expanded use in adults aged between 50 and 59, who are at increased risk of severe RSV disease.

GSK plc (GSK) said on Monday that its application for extending the use of its respiratory syncytial virus (RSV) vaccine Arexvy to adults aged 18-49 who are at increased risk of contracting the ...

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

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 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 syringe removes the need to reconstitute separate vials prior to administration, which simplifies the vaccine administration process for healthcare professionals, GSK said Thursday. The existing ...

GSK (GSK) stock in focus as the U.S. FDA approves a new prefilled syringe presentation of its shingles vaccine, Shingrix.

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 ...

GSK specialty medicines grew YoY in Q1 2025, and it is now the main profit engine, offsetting the weakness in their vaccine ...