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

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

The Food and Drug Administration has approved a new drug from Merck designed to protect infants from respiratory syncytial ...

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 ...

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

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

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

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

A newly approved shot could soon help protect babies from respiratory syncytial virus (RSV), the top cause of hospitalization ...

The simplicity of Merck's monoclonal antibody for RSV in infants could be a plus in its competition with AstraZeneca's existing treatment.

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

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 ...