RALEIGH, N.C., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, Inc. today announced that its Chief Executive Officer, Shalin Shah, will speak at the FDA Expert Panel on Testosterone Replacement Therapy for Men, taking place on December 10, 2025. This landmark event marks a pivotal moment in the advancement of men’s health and represents a major milestone for Marius, which has worked for years to elevate the scientific conversation surrounding testosterone and address longstanding misconceptions.
The public discussion will be led by Assistant Secretary of Health and Human Services, Dr. Brian Christine, a board-certified urologic surgeon and national leader in sexual medicine. Shah will join an esteemed group of panelists offering scientific, clinical, and regulatory insights into the risks, benefits, and appropriate use of testosterone replacement therapy.
As part of the event, the FDA will also open a public docket to gather questions, comments, and data related to testosterone therapy, including evidence that may support updates to product labeling. This reflects a meaningful regulatory shift toward reevaluating entrenched assumptions and providing clearer guidance for therapies that millions of men depend on.
“The FDA turning its attention to testosterone, a fundamental driver of metabolic health, is a landmark development,” said Shalin Shah, CEO of Marius. “Decades of misconceptions have slowed progress. This panel is a necessary course correction—bringing the science back to where it belongs and ensuring patients and prescribers can rely on the most current clinical evidence.”
This men’s health forum follows the success of the FDA’s earlier expert panel on hormone replacement therapies for women, which received highly positive public feedback. Building on that momentum, the FDA is now turning its attention to men’s health in an effort to bring balance, clarity, and scientific rigor to hormone therapy conversations.
For Marius Pharmaceuticals, the panel represents years of advocacy to promote accurate, evidence-based understanding of testosterone and support broader, appropriate usage of testosterone therapy for men who need it.
The event will be livestreamed for those who cannot attend in person. Viewers can watch from 1–3 PM ET at the following link: https://www.youtube.com/live/BdAawJmQ9Fs.
For more details about the FDA Expert Panel and how to register, visit https://www.fda.gov/patients/fda-expert-panels/fda-expert-panel-testosterone-replacement-therapy-men-12102025.
About Marius Pharmaceuticals
Marius Pharmaceuticals strives to better the lives of patients by focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company's vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com.
Media Contact:
Lilly Washburn
lilly@mariuspharma.com
