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

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 ...

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Arexvy is currently approved for use in all individuals aged 60 and older, as well as for high-risk individuals aged 50-59.

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

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 ...

Moderna 首席执行官 Stéphane Bancel 在新闻稿中表示：“FDA 批准我们的第二款 [RSV] 产品 mRESVIA，这建立在我们 mRNA 平台的优势和多功能性之上。”“mRESVIA 可保护老年人免受 RSV 感染的严重后果，它是唯一一种采用预填充注射器的 RSV 疫苗，旨在最大限度地提高给药的便利性，节省接种者的时间并降低管理错误的风险。” ...

"A regulatory decision by the FDA on this submission is expected in H1 2026. GSK is continuing to seek expanded indications for its RSV vaccine in other geographies including in the European Economic ...

Respiratory syncytial virus (RSV) infections were associated with significantly increased risk for complications beyond ...

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 regulator has issued a warning to NHS health staff about a small increased risk of a rare condition affecting ...