Risk of “acute, serious, and life-threatening” heart inflammation is now on the label of Sarepta's gene therapy for Duchenne ...

The Food and Drug Administration is scrutinizing the common practice of giving coronavirus and flu shots together, signaling a reversal of years of federal guidance and a broader crackdown on ...

The U.S. Food and Drug Administration said on Wednesday that it has launched a pilot program to give drugmakers faster answers to follow-up questions after formal meetings with the agency.

At long last, the Food and Drug Administration will remove a “black box warning” label required on the packaging of most ...

Food and Drug Administration (FDA) commissioner Marty Makary speaks during a news conference on the FDA's intent to phase out the use of petroleum-based synthetic dyes in the nation's food supply at ...

Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact ...

The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies ...

Alzheimer’s disease is a devastating condition that affects more than 7 million Americans, according to the Alzheimer’s Association. As the Baby Boomer generation ages, this number is estimated to ...

The FDA has outlined a new review process for drugs and biologics designed to treat ultrarare genetic diseases that would allow a single-arm trial, plus other supportive data, to serve as pivotal ...