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

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 ...

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 ...

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

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

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 ...

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 ...

U.S. FDA Approves Merck’s ENFLONSIA™ (clesrovimab-cfor) for Prevention of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease in Infants Born During or Entering Their First RSV ...