GSK's RSV jab secures FDA label expansion to larger adult population [Yahoo! Finance]
Pfizer, Inc. (PFE)
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Source: Yahoo! Finance
the US Food and Drug Administration (FDA) – broadening the jab's commercial reach on American soil. Through this new approval, Arexvy will be available as a preventative measure to non-pregnant adults aged between 18 and 49 years of age, provided they are at increased risk of developing RSV-associated lower respiratory tract disease (LRTD). The FDA based its decision on data from a global Phase IIIb trial (NCT06389487), which confirmed Arexvy's non-inferiority in immune response across the 18 to 49 age range compared with that seen in patients over 60 in a separate Phase III study (NCT04886596). Arexvy made its market debut in 2023 after becoming the first RSV vaccine to secure regulatory approval in the US – though the shot was originally indicated for the 60+ age demographic only. GSK later secured a label expansion for Arexvy into the 50-59 age category. Since its original approval, Arexvy has encountered competition from both Moderna and Pfizer, as the two pharma companies
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PFE
Earnings
- 2/3/26 - Beat
PFE
Sec Filings
- 3/16/26 - Form 4
- 3/12/26 - Form ARS
- 3/12/26 - Form DEFA14A
- PFE's page on the SEC website