Merck Receives FDA Approval For Supplemental Biologics License Application For ENFLONSIA To Expand Indication To Prevention Of Respiratory Syncytial Virus Lower Respiratory Tract Disease In Children Under Two Years Of Age At Increased Risk For Severe RSV Disease; PDUFA Date Set For March 22, 2027
In July 2026, the European Medicines Agency (EMA) accepted the application to expand marketing authorization for ENFLONSIA in the European Union (EU) for the same population.ENFLONSIA was approved by the U.S. FDA in
Merck got permission to use its medicine ENFLONSIA to help protect very young babies from a serious virus called RSV. This shows the medicine is working well enough for a new group of patients, which could mean more people buying it.
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