Members of an FDA expert panel urged the agency to expand labeling for testosterone replacement therapy and remove its ...

The narrow FDA labeling makes it so that only a minority of men who could benefit from treatment are considered ‘on-label’ ...

An FDA panel pushes reclassify testosterone therapy by recommending removal of controlled substance status and expanding treatment eligibility.

Promo materials should also refrain from positioning one approved biosimilar as better than another for the same reference ...

Health care professionals can have a powerful impact on labeling requirements for drugs by formally petitioning the FDA for ...

In a closely watched case, the U.S. solicitor general urged the Supreme Court to review a controversy over so-called skinny ...

In a closely watched case, the U.S. solicitor general has urged the Supreme Court to review a controversy over so-called ...

The FDA's proposed rule would require food manufacturers to put "Nutrition Info" boxes on the front of their packages stating ...

The agency’s proposed rule would require the display of a compact informational box containing certain nutrient information.

The U.S. Food and Drug Administration has approved an updated label for Unloxcyt (cosibelimab-ipdl) for the treatment of ...