NovaGenix Insights

A Decade of Data: How the TRAVERSE Trial Reshaped the FDA's Testosterone Guidelines   From Caution to Clarity: The FDA's Evolving Stance on Testosterone Warnings (2015 vs. 2025) In the realm of public opinion, even that of healthcare professionals, there has been a great deal of misconceptions involving the safety and efficacy of testosterone when used as a medication in the past several decades.   This is mostly based on faulty research and clinical trials that were poorly designed and easily disproven. Medical guidance and governance of testosterone replacement therapy (TRT) has been significantly shaped by regulation from the U.S. Food and Drug Administration (FDA) which has finally taken a more educated approach and is now saying what many of us have known all along. In 2015 , the FDA issued a stringent label warning for testosterone products, largely driven by concerns about heart health and potential cardiovascular risks. This warning was concerning to many patients an...

Why Won't My Doctor Prescribe Testosterone? Legal Considerations for Patients on TRT As men get older, many will begin experiencing symptoms related to low T. Symptoms like feeling tired all the time, having a decreased sex drive, losing muscle mass, and even experiencing mood changes are just a few of the more common symptoms associated with age related testosterone decline. With so much media attention, clinical research and information regarding TRT that people now have access to, the thought of boosting testosterone levels seems like a straightforward solution for many men. Yet, we continuously hear from a significant number of patients that come to us that their doctors are hesitant or unwilling to test for or prescribe testosterone replacement therapy (TRT). This obviously is a source of frustration and confusion, leading many to come to us and seek answers regarding how to best move forward with optimizing their testosterone levels. At NovaGenix Health and Wellness, we bel...

  What Will Tariffs Mean for Testosterone? Preparing for the Potential Impact on HRT Long gone are the days of local mom and pop pharmacies serving the entire town in the US. We now live in an increasingly globalized world, and the ripple effects that international trade policies can have may be felt in unexpected corners, even when it comes to the personal health and wellness industries, whether you’re a supplier, provider or patient. For men and women undergoing Testosterone Replacement Therapy (TRT) or Hormone Replacement Therapy (HRT) or those just considering it, recent talks in the news media about President Donald J. Trump and his recent tariffs might seem distant from their daily medical regimen, however, trade tariffs on pharmaceutical ingredients , particularly active pharmaceutical ingredients (APIs) and excipients, may eventually have quite a serious impact on the both the accessibility and affordability of testosterone and other hormone replacement therapy medicati...