On July 9, 2025, the U.S. Food and Drug Administration (FDA) issued a letter from Commissioner for Human Foods Martin Makary and Deputy ...

George Francis Tidmarsh, MD, PhD, founding co-director of Stanford’s Master of Translational Research and Applied Medicine ...

The Food and Drug Administration is calling on industry to provide input on how to better institute recalls, particularly for food for infants. In a ...

Company CEO Doug Ingram said the pause was necessary for Sarepta to maintain a "productive and positive working relationship" ...

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view | ...

The agency also revoked Sarepta's platform technology designation for AAVrh74 Friday and issued a safety communication saying ...

Recent actions by the Food and Drug Administration (FDA or Agency) reflect a sharpened scrutiny in areas where public health and safety may ...

The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and ...

Kezar Life Sciences' zetomipzomib trial in autoimmune hepatitis resumes as FDA lifts partial hold following a favorable safety review.

FDA says the move boosts regulatory transparency, offering insights into common approval barriers in drug applications and reducing guesswork.

The FDA has introduced Elsa, an internal AI tool to review safety data, identify labeling issues, and prioritize inspections, potentially speeding up responses to food safety issues like recalls.

Karnataka government assigns licensing authority role to Dr Umesh S, additional drugs controller of state FDA: Our Bureau, ...