KUALA LUMPUR, Dec 16 — Sanofi and AstraZeneca’s Beyfortus (Nirsevimab) is now approved by the National Pharmaceutical ...
Federal regulators have begun a safety review of 2 RSV medicines used to protect infants, even though no safety problems have been reported.
The Centers for Disease Control and Prevention alerted doctors nationwide Monday about a limited availability of certain doses of a newly approved antibody drug given to infants to prevent RSV ...
FDA officials have opened a safety review of two injectable RSV drugs used to protect babies and toddlers from the ...
The Food and Drug Administration has launched a safety review of two approved RSV drugs for infants, the latest immunizations ...
FDA reexamine infant RSV therapies with Sanofi, AstraZeneca, and Merck amid safety concerns and data review under new FDA leadership.
Just a few months after Sanofi and AstraZeneca scored a key FDA nod for their respiratory syncytial virus (RSV) antibody Beyfortus, the long-awaited prophylactic is already in short supply. In an ...
If confirmed, the safety review could herald the imposition of restrictions on the use of the antibodies by HHS, which has ...
87% reduction in cases of respiratory syncytial virus (RSV) disease across all sites of care among healthy, term babies, born ahead of or during the RSV season 98% reduction in hospitalizations of ...
As an FDA official said that the agency has evidence that links COVID vaccines to the deaths of at least 10 children, the U.S ...
Sanofi’s plan to become a dominant player in the respiratory syncytial virus (RSV) market has moved a step closer, with FDA approval of Beyfortus for the prevention of RSV disease in infants. The US ...