Objective Postmarketing safety data of avacopan, the first Food and Drug Administration (FDA) approved drug in a decade for ...

Clinical trial data showed that some side effects attributed to statins on product labels rose above the level of likely false discovery due to multiple comparisons. Statins contributed less than 0.1% ...

The addition of pembrolizumab to chemotherapy in high-risk early triple-negative breast cancer (TNBC) improves cancer outcomes. However, pembrolizumab induces varied immune-related adverse events ...

WASHINGTON - The Food and Drug Administration has launched what it is describing as a "unified dashboard" for identifying and monitoring unexpected side effects or injuries caused by approved medical ...

FIRST ON FOX: The Food and Drug Administration (FDA) rolled out a new platform, backed by artificial intelligence, that will streamline publicly accessible reporting of negative or unexpected health ...

Health care workers face adverse events daily. These events include secondary trauma, occupational trauma, unexpected death or injury, moral injury, medical error and ...

It’s out with the old, in with the new at the FDA as the agency is unveiling a new adverse events monitoring system that joins several reporting systems into one unified platform, an effort that’s ...