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 ...

Federal regulators have begun a safety review of two RSV medicines used to protect infants, even though no safety problems have been reported.

U.S. health regulators informed senior executives at Merck, Sanofi and AstraZeneca last week that their approved protective ...

Merck (NYSE:MRK) has received FDA approval for Enflonsia, a prophylactic antibody therapy designed to protect infants from respiratory syncytial virus (RSV) in a market dominated by Beyfortus, a rival ...

Food and Drug Administration officials have opened a safety review of two injectable drugs used to protect babies and ...

In this morning's Pharmalittle roundup, we're reading about FDA scrutiny of RSV therapies, an AI tool for clinical trials, ...

A wall showing a Merck & Co. logo in Kenilworth, New Jersey This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive ...

FDA reexamine infant RSV therapies with Sanofi, AstraZeneca, and Merck amid safety concerns and data review under new FDA leadership.

Please provide your email address to receive an email when new articles are posted on . Clesrovimab is a monoclonal antibody that protects against RSV subtypes A and B. The FDA set a PDUFA date for ...

The Food and Drug Administration on Monday approved Merck's shot designed to protect infants from respiratory syncytial virus during their first season of the virus, bringing to market a rival to a ...

The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, New Jersey (Reuters) -The U.S. Food and Drug Administration on Monday approved Merck's preventive antibody shot to ...