Biogen Inc. raised its full-year financial guidance as growing sales of its Alzheimer’s drug helped the biotech company beat ...

There’s no questioning that AI should have governance and guardrails. As much good as it can bring, it also heightens risk.

In a 51–47 vote along party lines, the Senate confirmed Monarez as the director of the Centers for Disease Control and ...

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...

Among 24 such systems (called devices in FDA parlance) authorized since 2015, FDA summaries for 14 lacked data on the ...

Explore the FDA’s 2025 Human Foods Program Guidance Agenda and what it means for US food and beverage businesses. Key ...

U.S. Food and Drug Administration Commissioner Marty Makary said he is focused on overhauling long-held standards and ...

Speakers at a congressional briefing on July 22 called on the FDA to take action against the marketing and distribution of ...

In recent months, U.S. Food and Drug Administration Commissioner Dr. Marty Makary has amplified unfounded concerns about the ...

On Sunday, the Caldwell County Sheriff’s Office conducted a drug search that led to the arrest of Paul Witherspoon.

Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...