There are no U.S. approved vaccines for RSV, a common virus that typically causes mild cold-like symptoms but can be fatal for young kids and older adults. RSV is estimated to cause about 14,000 annual deaths among older adults in the United States.
Updated data released on Tuesday showed 13 children had COVID-19, at least seven days after receiving a third dose of the Pfizer-BioNTech COVID-19 vaccine, compared with 21 cases among those who received a placebo.
Xofluza is the first and only single-dose oral medicine for the treatment of influenza to be approved in the United States for children as young as five years of age. The FDA also approved the drug to prevent influenza in children aged five years and older following contact with an infected person.
The FDA’s nod extends Benlysta’s indication in the US, making it the first approved treatment for pediatric lupus nephritis. Benlysta was also the first approved targeted therapy for lupus nephritis in adults in 2011.
The digital health company touts its approval for the first and only machine learning algorithm to assist healthcare professionals in identifying structural heart murmurs using a smart stethoscope.