Federal health officials are reviewing the safety of two injectable drugs used to protect babies and toddlers from the RSV ...

A U.S. regulatory decision on tolebrutinib will again be delayed while a late-stage trial of the drug for a different form of ...

Pro-life groups are holding the U.S. Food and Drug Administration and its commissioner Marty Makary accountable for leaving ...

Medical experts are concerned that a panel discussion convened by the Food and Drug Administration could lead to more cases ...

The U.S. Food and Drug Administration (FDA) has been rocked by recent changes to several leadership roles while it has ...

Ophirex announced that varespladib, which is also being developed as an oral rescue treatment for snakebite envenomation in ...

The Food and Drug Administration has launched a safety review of two approved RSV drugs for infants, the latest immunizations ...

The U.S. Food and Drug Administration approved on Tuesday the first drug under its new fast-track program designed to shorten ...

For the first time in decades, the US Food and Drug Administration has signed off on new antibiotics to fight gonorrhea. The approvals come at a critical moment: The sexually transmitted infection is ...

The U.S. Food and Drug Administration has qualified the first artificial intelligence tool designed to help doctors assess a ...

In her nine months as scientific adviser to U.S. Food and Drug Administration Commissioner Marty Makary, Tracy Beth Høeg’s ...

Myocarditis is a known — but small — side effect of the mRNA Covid vaccines from Pfizer and Moderna, information that federal ...