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NMPA Accepts GSK’s Arexvy Submission to Prevent Lower Respiratory Tract Disease in Adults

Shots: The Chinese NMPA has accepted the application of Arexvy RSV vaccine for the prevention of LRTD caused by respiratory syncytial virus (RSV) in adults aged ≥60yrs.; regulatory decision is expected by 2027 Submission was based on extensive clinical data, incl. results from the P-III trial assessing safety & immunogenicity of Arexvy in adults (≥60yrs.)…
February 10, 2026

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GSK New
NEWS

GSK’s Arexvy Receives the EC Approval to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: The EC has approved the Arexvy RSV vaccine for adults ≥18 yrs in Europe. While it was previously authorized only for adults ≥50 yrs at risk The adjuvanted RSV vaccine includes a stabilized form of a protein from the respiratory syncytial virus (RSV), called the prefusion F protein (RSVPreF3), combined with GSK’s AS01E adjuvant,…
January 27, 2026

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Top 20 Vaccines of 2025
TOP 20

Top 20 Vaccines of 2025 

Shots:  Vaccines play a critical role in combating infectious diseases by stimulating antibody production and establishing immune memory. Biopharma companies around the globe continue to drive innovation in vaccine development, targeting both infectious and preventable diseases  The global vaccine market was valued at $87.75B in 2024 and is projected to reach $151.96B by 2033, reflecting…
July 17, 2025

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NEWS

GSK Reports the US FDA’s Application Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: The US FDA has accepted application of Arexvy RSV vaccine for adults aged 18-49yrs. at increased risk, expanding its use beyond those aged ≥50yrs.; FDA decision is anticipated H1’26. GSK is also seeking expanded RSV vaccine indications in other regions, incl. the EEA & Japan Submission was based on P-IIIb trial (n=1458) assessing immune response & safety…
July 14, 2025

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GSK New
NEWS

GSK Reports the MHLW’s sNDA Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: Japan’s MHLW has accepted sNDA of Arexvy RSV vaccine for adults aged 18-49yrs. at increased risk, expanding its use beyond those aged ≥50yrs. Submission was based on P-IIIb trial (n=1458) assessing non-inferiority & safety of Arexvy RSV vaccine in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429); an additional cohort (18-49yrs.; n=603) was followed for…
June 20, 2025

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