MRK wins early FDA approval for RSV antibody Enflonsia in infants, with U.S. launch planned before the 2025-26 season.

Known as Enflonsia, the drug will compete for market share with Sanofi and AstraZeneca’s in-demand Beyfortus, which quickly ...

Meanwhile, Sanofi has pointed to Beyfortus’ 75% reduction in the incidence of MALRI versus Enflosia’s figure of 60%. The ...

Merck’s Enflonsia (clesrovimab) has received US Food and Drug Administration (FDA) approval for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns ...

Merck’s Enflonsia will go up against Sanofi and AstraZeneca’s Beyfortus, which the partners plan to ship out early in the ...

Approval of Enflonsia was based on data from the Phase IIb/III CLEVER trial, which showed a 60.5% reduction in medically ...

The FDA has approved Enflonsia (clesrovimab-cfor) for the prevention of RSV lower respiratory tract disease in neonates and ...

The Food and Drug Administration has approved a new drug from Merck designed to protect infants from respiratory syncytial virus, or RSV, a common but potentially serious seasonal illness.

Li, president, Merck Research Laboratories. “We are committed to ensuring availability of ENFLONSIA in the U.S. before the start of the upcoming RSV season to help reduce the significant burden ...

Rahway: Merck, known as MSD outside of the United States and Canada, has received approval from the U.S. Food and Drug ...

The United States could soon have another tool in the fight against respiratory syncytial virus, an illness that’s the No. 1 ...

In a major boost for infant health, the U.S. Food and Drug Administration (FDA) has approved ENFLONSIA ™ (clesrovimab-cfor), ...