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The FDA is launching a safety review of #RSV preventive monoclonal antibodies #nirsevimab and #clesrovimab. Reuters reported that FDA officials made inquiries into the RSV preventive therapies in the summer. #medsky

Full details: www.contemporarypediatrics.com/view/reports...

#RSV causes 100,000 child deaths yearly — almost entirely in LMICs. On #WPD, MPP calls for urgent action to make prevention tools like #nirsevimab and #clesrovimab widely accessible, esp. in LMICs.

Voluntary licensing can help close the gap. Learn more: medicinespatentpool.org/story-post/p...

#Medsky🧪 #IDsky #pedsky #pharmsky #publichealth
In healthy preterm and full-term infants, a single dose of #clesrovimab reduced the incidence of RSV-associated medically attended lower respiratory infection & RSV-associated hospitalization, with a safety profile similar to that of placebo.

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 Season - ... ENFLONSIA is a preventive monoclonal antibody designed to protect infants against a spectrum of RSV disease severity, including worsening disease requiring hospitalization ENFLONSIA is the first and o...

#Clesrovimab recibe aprobación por la FDA para la prevención del Virus Respiratorio Sincitial #VRS en infantes. Muy positiva noticia dada a conocer hoy y aumentan las opciones de prevención. #rsv #stoprsv
www.merck.com/news/u-s-fda...

Novel Drug Approvals for 2025 Novel Drug Approvals for 2025

#Medsky🧪 #IDsky #immunosky #pedsky #pharmasky #publichealth @fda.gov approves Enflonsia ( #clesrovimab ), a single-dose monoclonal antibody indicated to prevent RSV - LRT in neonates & infants born during or entering their 1st RSV season

www.fda.gov/drugs/novel-...