Drug Approval | June 12, 2025
FDA approves Merck’s enflonsia for prevention of RSV in infants
Enflosina is a long-acting monoclonal antibody that provides direct protection for up to 5 months
Enflosina is a long-acting monoclonal antibody that provides direct protection for up to 5 months
Vote expands existing recommendation, which was for all adults aged 75 and older and high-risk adults aged 60 to 74
An investigational long-acting monoclonal antibody designed to protect infants from RSV disease during their first RSV season
Data demonstrate the importance of protecting against serious respiratory infections caused by respiratory syncytial virus, human metapneumovirus and COVID-19
Palivizumab (Synagis) is indicated for the prevention of serious lower respiratory tract disease requiring hospitalization caused by RSV in children at high risk for RSV disease
These results add to the growing body of evidence indicating a single dose of ABRYSVO provides strong immune protection against outcomes caused by RSV
Decision on EU marketing authorisation for this population expected by September 2024
Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of severe RSV outcomes
mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes
U.S. FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of May 12, 2024
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