Drug Approval | May 12, 2023
USFDA approves GSK’s respiratory syncytial virus vaccine ‘Arexvy’
Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time
Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time
Bayer reported the highest market capitalization growth of 23.1% during Q1 2023
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
The safety profile of LAGEVRIO in this trial was generally consistent with that observed in previously reported clinical studies
mRNA-1345 demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease, defined by 2 or more symptoms in older adults
Moderna and Merck announced mRNA-4157/V940, in combination with KEYTRUDA, demonstrated a 44% reduction in the risk of disease recurrence or death in melanoma patients
QS-21 in blockbuster Shingles vaccine, first vaccine approved for Malaria, promising RSV phase III candidate, and Covid-19 applications.
This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
RSV is the most common viral cause of respiratory tract infections in newborns, young children, older adults, or the immunocompromised
Pfizer calls upon global health leaders and organizations to join the Accord, bringing their expertise and resources to close the health equity gap
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