The FDA has recommended several labeling changes to all approved testosterone replacement therapy products based on the ...

“Abrupt” reductions in antidepressant treatment “ranging from 20 percent to 50 percent” Increases in psychotropic drug ...

The TRAVERSE trial, a large-scale clinical study with over 5,000 patients, published in 2023, concluded that TRT does not increase the risk of adverse cardiovascular outcomes in men with hypogonadism.

But while nutrition experts have welcomed the FDA’s proposed policy change, the addition of warning labels to packaged goods hasn’t been shown to reduce the very real burden of chronic diseases.

Purpose: Data collected from the Food and Drug Administration (FDA) under the Freedom of Information Act are presented to help clinicians understand the data prompting the black-box warning for ...

"The removal of the box warning and long anticipated scientific conclusion opens ... The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 ...