Regulation
10 articles tagged “Regulation”
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Federal Men's Health Office Stalls. What It Means for TRT
The State of Men's Health Act has bipartisan support but faces political headwinds. Here's what the proposed federal office means for testosterone access.

Aviva AVA-291: Aromatization-Resistant Testosterone for Women
Aviva Bio's AVA-291 is a deuterium-modified testosterone designed to resist aromatization and lower breast-cancer-cell-proliferation signal by approximately 1,000-fold.

Acrux Advances Female Testosterone to Phase 3 for HSDD
On April 30, 2026, Acrux announced Phase 3 trials for a transdermal female testosterone product for HSDD. Here is what it means and what is available now.

Generic Premarin Approved: Cheaper HRT in 2026
FDA approved the first generic conjugated estrogens in 30+ years. Prices, pharmacy availability, and whether to switch from brand Premarin.

FDA Opens TRT Pathway for Low Libido in Men
On April 16, 2026, the FDA asked TRT manufacturers to seek approval for low libido in idiopathic hypogonadism. Here's what it means for patients now.

HRT Black Box Warning Removed: What Changed
The FDA removed black box warnings from HRT products in 2025. Prescriptions surged 184%. Here's what the science says and what to do next.

FDA May Descheduling Testosterone: What It Means
An FDA panel recommends removing testosterone's Schedule III status and expanding access to age-related low T. Here's what changes and what to do now.
Treatment

New Pharma Tariffs Could Raise TRT and HRT Costs
100% tariffs on imported pharmaceutical ingredients take effect in 2026. How they affect testosterone, estrogen, and compounding pharmacy prices.

Compounded TRT and HRT: Where the FDA Stands Now
The FDA proposed banning compounded testosterone and bioidentical hormones. After Commissioner Makary's signal, here's where things actually stand.
