Shots:
FDA has accepted the sBLA of Enflonsia to prevent RSV lower respiratory tract disease (LRTD) in children (<2yrs.) at increased risk for severe RSV disease through their second RSV season (PDUFA: Mar 22, 2027); application is also under EMA review
Submissions were supported by P-III (SMART/MK-1654-007) trial assessing Enflonsia in infants & children over…
