An FDA panel of experts has called for a loosening of regulations and expanding access to testosterone replacement therapy.

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

The drugs have soared in popularity, with some men taking them for unapproved uses like anti-aging or increasing muscle mass.

Dr. Helen Bernie said on a Dec. 10 panel hosted by the U.S. Food and Drug Administration that serum testosterone "is one of ...

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

Jatenzo (testosterone undecanoate) is a prescription drug that’s used to treat low testosterone levels. The drug comes as a capsule that you swallow. It’s usually taken twice per day. Jatenzo is ...

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