Credit: Getty Images. The BLA acceptance was supported by data from the randomized, placebo-controlled phase 2b/3 CLEVER trial as well as interim data from the ongoing phase 3 SMART trial. A ...
WASHINGTON (AP) — Food and Drug Administration officials have opened a safety review of two injectable drugs used to protect babies and toddlers from RSV, the respiratory virus that sends thousands of ...
The recent safety review of two approved RSV preventive treatments for infants initiated by the U.S. Food and Drug Administration is unusual and could have unintended consequences for public trust and ...
The Food and Drug Administration has launched a safety review of two approved RSV drugs for infants, the latest immunizations to face scrutiny under Health Secretary Robert F. Kennedy Jr. No safety ...
The review demonstrates that vaccines for respiratory syncytial virus (RSV) are both safe and effective in protecting groups who are most at risk for serious illness, including older adults and ...
FILE - The U.S. Food and Drug Administration building is seen behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md., Aug. 2, 2018. (AP Photo/Jacquelyn Martin, File) WASHINGTON ...
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