The FDA has removed a pause in the use of Valneva’s chikungunya vaccine in older adults while tweaking the shot’s label with stricter language.

"Based on the available data, and its benefit-risk assessment, FDA has removed the recommended pause in the use of Ixchiq in ...

The FDA is requiring opioid pain medication manufacturers to update safety labeling with a stronger emphasis on risks from ...

The Food and Drug Administration July 31 announced that it is requiring safety label changes to all opioid pain medications ...

The FDA is updating opioid safety labels to support treatment decisions based on the latest evidence to reduce misuse.

The U.S. Food and Drug Administration is taking significant steps in the ongoing fight against the Opioid Crisis.

Teva (TEVA) stock in focus as the FDA expands label for its migraine therapy Ajovy for children and adolescents aged 6–17 years. Read more here.

April 1, 2014 Generic Drug Labeling ... Witnesses testified at a hearing on the Food and Drug Administration’s FDA’s proposal to have generic drug makers update their safety… read more ...

With more than 80 percent of the prescriptions in the U.S. filled with generic drugs, the FDA said it is important for generic manufacturers to be actively involved in making sure drug labels are ...

The new labels will make it easier to find and understand critical information as women and their doctors decide what prescription drugs to use, said Cynthia Pellegrini of the March of Dimes ...