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

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 ...

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

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

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 ...

Three specific Power Stick antiperspirant varieties are being recalled nationwide after failing to meet safety manufacturing ...

Knockoff copies of Novo’s weight loss medicine Wegovy have held back sales and put the drugmaker on the back foot in its ...

The CEO said that the FDA's regulation of sunscreen, particularly for organic products, was "impossible" to meet.