(CercleFinance.com) – GSK announces that the European Medicines Agency (EMA) has received its application for marketing authorization (MA) for GSK’s vaccine candidate intended to fight against respiratory syncytial virus ( RSV) in the elderly.
Marketing authorizations may be eligible for accelerated assessment if the EMA’s Committee for Medicinal Products for Human Use decides that the product is of major interest for public health and therapeutic innovation.
A European regulatory decision is expected in the third quarter of 2023.
If approved, GSK’s RSV vaccine candidate for older adults has the potential to be the first vaccine available to help protect older adults against lower respiratory tract disease (LRTD).
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