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 ...

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

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 ...

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 ...

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

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

FDA officials are newly scrutinizing several approved therapies to treat RSV in babies despite the fact that these shots were shown to be safe in clinical trials ...

The FDA began a safety review of RSV monoclonal antibody treatments for infants despite the products' safety records.

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 decision will allow the company to launch the drug, which will be marketed as Enflonsia, ahead of the RSV season that typically kicks off around fall and winter and lasts through the spring. Merck ...

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

The agency also is reviewing safety of immunizations for RSV, according to manufacturers of the therapies who have been ...