The U.S. Food and Drug Administration announced approval of nirsevimab, sold under the name Beyfortus, in a press release Monday. The drug is designed to prevent respiratory syncytial virus lower respiratory tract disease in babies born during or entering their first RSV season, as well as in vulnerable children up to age 2 who are more susceptible to severe illness within their second RSV season. Dr. John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in the release, “Today’s approval...

The Food and Drug Administration on Monday approved a new drug, Beyfortus (nirsevimab), to protect young children from the deadly infection known as respiratory syncytial virus (RSV). Worldwide, RSV is the second-leading cause of death during the first year of a newborn’s life, second only to malaria, according to Nature Journal. Infants six months and younger have an even higher risk of becoming extremely ill. Globally, about 120,000 babies die from RSV every year. “RSV can cause serious disease in infants and some children and results in a large number...

U.S. drug regulators have approved a drug aimed at preventing a respiratory disease in babies and toddlers. The U.S. Food and Drug Administration (FDA) on July 17 cleared Beyfortus, a monoclonal antibody that prevents respiratory syncytial virus (RSV), a lower respiratory tract disease. Children up to 24 months of age can now receive the drug, which showed efficacy in several clinical trials. “RSV can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year,” Dr. John Farley,...

Last November the Maples family was living day to day. "We were looking for any sort of light at the end of the tunnel," Jamie Maples said via Zoom with his family now stuck at home battling COVID. CBS News Colorado first spoke with the Maples family last fall, as the cases of RSV skyrocketed across Colorado and their 4-year-old daughter Meadow had contracted a severe case leading to her having to be intubated for eight days. RELATED: 'Thanksgiving miracle:' 4-year-old goes home after 24 days in Denver hospital with...

The Food and Drug Administration approved the monoclonal antibody treatment Beyfortus to prevent respiratory syncytial virus—the leading cause of hospitalizations in U.S. infants less than a year old.

The drug—made by AstraZeneca—will be administered as a single injection to infants prior to RSV season in the latter months of the year. Around 2% of children less than a year old are hospitalized by RSV every year, according to the American Academy of Pediatrics.

This is a developing story. Check back for updates.

The U.S. Food and Drug Administration on Monday approved a Sanofi SNY, and AstraZeneca PLC AZN, respiratory syncytial virus vaccine for newborns and infants. The RSV vaccine, Beyfortus, was approved for prevention of RSV lower respiratory tract disease in babies entering their first RSV vaccine as well as children up to two years old who remain vulnerable to severe RSV, the FDA said in a release. RSV typically causes mild, cold-like symptoms but can be serious, particularly in infants and older adults. AstraZeneca’s ADR was down 0.6% on Monday, while...

The Food and Drug Administration (FDA) has approved a treatment for the prevention of RSV among infants and toddlers, making it the first preventive for the common virus that surged last winter among small children. The FDA approved nirsevimab-alip, or Beyfortus, for the prevention of RSV among newborns and infants born during or entering into their first RSV season, which typically starts in the fall, peaks in the winter and ends in the spring. Beyfortus is a monoclonal antibody administered in one dose. The safety of efficacy of the medicine...

Sanofi plans to make Beyfortus available in time for this year’s RSV season. Parents have a new tool to protect their newborns from a common but potentially deadly respiratory virus that sends tens of thousands of babies to the hospital each year. The Food and Drug Administration approved the first drug to protect all infants against respiratory syncytial virus. RSV is the leading cause of hospitalization of infants in the U.S., killing as many as 300 children under the age of 5 each year. The FDA said it approved the...

The Food and Drug Administration on Monday approved AstraZeneca and Sanofi 's shot that protects infants and toddlers against respiratory syncytial virus, which is the leading cause of hospitalization among infants in the U.S. Nirsevimab is the first shot approved by the FDA to protect all infants against RSV regardless of whether they are healthy or have a medical condition. The FDA approval of nirsevimab comes several months ahead of RSV season this fall. The Centers for Disease Control and Prevention's panel of independent experts will meet in August to...