Healio11d
FDA recommends removing black box warning for CV risk from all testosterone product labels
The FDA has recommended several labeling changes to all approved testosterone replacement therapy products based on the ...
Marius Pharmaceuticals Helps Drive FDA’s Landmark Testosterone Label Update, Removing Black Box Warning
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.
Yahoo Finance11d
Marius Pharmaceuticals Helps Drive FDA’s Landmark Testosterone Label Update, Removing Black Box Warning
In September 2024, Marius Pharmaceuticals proactively submitted a Prior Approval Supplement (PAS) to the FDA, advocating for the removal of the Black Box Warning associated with testosterone products.