fda

In this episode, Dr. Brandon and Dr. Morgentaler talk about the FDA's groundbreaking testosterone label changes, the evolving evidence on testosterone therapy and prostate cancer, and how quality of life should factor into treatment decisions for men with advanced disease. Time stamps...

In this episode of AUANews Inside Tract, host Dr. Mark Edney speaks with Dr. Helen Burnie about the FDA’s proposed updates to testosterone therapy labeling and what they could mean for urologists, patients, and the broader field of men’s health. The discussion explores new evidence on...

https://mariuspharma.com/news/marius-pharmaceuticals-applauds-fdas-proposed-testosterone-labeling-updates-as-a-turning-point-for-mens-health/ The FDA’s second major labeling update in 16 months — after its February 2025 removal of the cardiovascular boxed warning — marks a historic...

https://www.hhs.gov/press-room/fda-requests-updates-testosterone-therapy-labeling.html The U.S. Department of Health and Human Services, through the U.S. Food and Drug Administration (FDA), announced today that it is requesting updates to the prescribing information for testosterone...

Born for this! https://www.renalandurologynews.com/features/mohit-khera-testosterone-therapy-for-men/ https://www.excelmale.com/threads/once-weekly-hcg-helps-preserve-fertility-in-men-on-testosterone-therapy-largest-study-yet.34086/

https://www.urologytimes.com/view/fda-grants-clearance-to-total-testosterone-assay The FDA has granted clearance to Revvity’s automated chemiluminescence immunoassay (ChLIA) for total testosterone measurement.1 The assay is designed to support diagnostic testing for androgen-related disorders...

Following the FDA’s announcement on a potential pathway to expand testosterone replacement therapy (TRT) labeling,1 leading experts in men’s health shared their perspectives on what this development could mean for patients and clinical practice.

https://www.ajmc.com/view/fda-signals-potential-expansion-of-testosterone-therapy-to-treat-low-libido-in-idiopathic-hypogonadism https://www.fda.gov/news-events/press-announcements/fda-takes-step-forward-testosterone-therapy-men The U.S. Food and Drug Administration today is taking an...

A major shift just happened in menopause care. With the FDA removing outdated boxed warnings on hormone therapy—first announced in November 2025 and finalized in February 2026—we’re entering a new era. But what’s actually changed, and what does it mean for patients and clinicians? Join Dr...

Panelists: Dr. Abraham Morgentaler Dr. Mohit Khera Dr. Martin Miner

Hitting the nail on the head here! * More than 30 years later, he argues that the regulatory framework no longer reflects current clinical evidence and may be doing more harm than good. In this episode, Arundhati Parmar interviews Shalin Shah, CEO of Marius Pharmaceuticals, about...

Much more to the story here! * Longer-term studies are still needed to determine whether testosterone therapy is safe with respect to cardiovascular, thromboembolic, and prostatic diseases. However, recent placebo-controlled trials (of 1-4 years) of TRT offer reassurance about the risk of...

All those so called gurus polluting social media and the half-wits pushing that more T is better mentality bull*** stinkin up those so called men's health/HRT forums! * At the same time, the non-medical environment has evolved, with online marketplaces, informal supply chains, and...

In this episode Dr. Mary Claire Haver is joined by Dr. Rachel Rubin, a board-certified urologist and nationally recognized expert in sexual medicine, fellowship trained in both female and male sexual health. As assistant clinical professor of urology at Georgetown University and former education...

In this episode, Dr. Morgentaler & Dr. Brandon talk about whether testosterone can be improved naturally, why supplements and diet fall short, and how outdated FDA policies and misconceptions continue to shape testosterone treatment today. Chapters 00:38 Testosterone Myths and Realities –...

https://www.medscape.com/viewarticle/fda-listened-estrogen-will-they-now-fix-testosterones-2026a10000na?form=fpf Rachel Rubin, MD Hello, everyone. I’m Dr Rachel Rubin, and we’re here for another episode of Sex Matters. I am thrilled to introduce two of my major mentors. I can’t say enough...

This session, hosted by Dr. Rachel Rubin, a leading Urologist and sexual medicine specialist, and Heather Florio, CEO of Desert Harvest, explores the intersection of hormonal health, sexual wellness, and interstitial cystitis (IC). Together, they’ll redefine what menopause means today —...

https://www.urologytimes.com/view/mohit-khera-md-recaps-key-takeaways-from-fda-panel-on-trt-for-men Mohit Khera, MD, MBA, MPH, recaps key takeaways from an FDA expert panel discussion on testosterone replacement therapy for men. In a recent interview with Urology Times®, Mohit Khera, MD, MBA...

The FDA encourages the public to comment in docket FDA-2025-N-6743 Expert Panel on Testosterone Replacement Therapy for Men. https://www.federalregister.gov/public-inspection/2025-22466/request-for-information-expert-panel-on-testosterone-replacement-therapy-for-men An unpublished Notice by...

The FDA just held a hearing on menopause—and experts say it’s time to rethink hormone labels. Dr. James Simon joins Fempower Health to explain what needs to change and what it means for women. Chapters: 00:00 Intro – Why This Conversation Matters 00:14 Why Estrogen Labels Matter 00:20...

* 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. * Shah will join an esteemed group of...

@Nelson Vergel We need you here! https://www.fda.gov/patients/fda-expert-panels/fda-expert-panel-testosterone-replacement-therapy-men-12102025 Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31, Great Room, Silver Spring, MD 20993-0002. There will be limited seating...

Dr. Rachel Rubin and Dr. Kelly Caspersen discuss with FDA Commissioner Dr. Marty Makary the significant impact of hormone replacement therapy (HRT) on women's health, particularly in the context of recent FDA changes to black box warnings. They explore the misconceptions surrounding HRT, the...

Eric Ruderman, MD, discusses the recent FDA approval of vagus nerve stimulation for rheumatoid arthritis. The approval was based on the findings from the RESET-RA trial, which involved multiple locations, including Northwestern Medicine. Dr. Ruderman provides insights on the trial, which...

Rachel Rubin, MD a urologist and sexual medicine specialist, discusses the critical need for physician and public engagement with the FDA on women's health. Learn how to advocate for the removal of inaccurate boxed warning labels on vaginal hormone therapies. Dr. Rubin highlights the immense...

* In March 2020, Federal law changed so that compounding several types of biological products, including HCG, became illegal.1 After the Biologics License Application (BLA) transition period ended, it became illegal to manufacture or market compounded HCG in the U.S. without a BLA. The FDA and...

* “[The label change] does not give a clean slate to [health care professionals] who are giving testosterone treatment to people who do not have low testosterone,” Dhindsa said. “[Some clinics] are overtreating men, and then they [need] a phlebotomy to deal with the effects of excessive...

Is one outdated warning label standing between millions of women and safe, effective care? In this episode of BackTable Urology, Dr. Yahir Santiago-Lastra, a urologist specializing in female pelvic medicine and reconstructive surgery at UC San Diego, joins host Dr. Suzette Sutherland to discuss...

* However, he noted there is still hope for the industry as Marius is currently developing an oral testosterone treatment for women. “Things are changing,” he said. “More and more people are recognizing this as a treatment, so there is a chance that it will be approved by the FDA soon.”...

https://www.urologytimes.com/view/ashley-winter-md-calls-for-label-update-on-low-dose-vaginal-estrogen "We are not offering patients comprehensive management unless we consider hormone therapies," says Ashley G. Winter, MD. On July 17, 2025, a panel of experts convened by the FDA outlined the...

The FDA finally held a hearing on menopause—and it was long overdue. Georgie Kovacs breaks down the powerful expert testimony, the systemic failures, and why this matters for every woman navigating midlife care. In this grounded recap, you’ll learn: • Why the FDA’s black box warning on...