The FDA has recommended several labeling changes to all approved testosterone replacement therapy products based on the ...
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.
Feb. 13, 2025 -- The FDA has approved a new three-drug combination to treat certain types of an aggressive blood cancer called large B-cell lymphoma (LBCL). LBCL is a fast-growing cancer of B ...
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.