Top FDA news in women's health you missed in Q1 2026

The first quarter of 2026 is all but in the books, with several noteworthy updates from the United States FDA having taken place. From federal agency feedback on testosterone therapy to updated labels for multiple menopausal hormone therapies, there was a lot to keep track of in women’s health in Q1.

Below, we walk you through our top FDA headlines from the first quarter with direct links for more information and, where available, expert insights via video interview.

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Top FDA news in women’s health: Q1 2026

On January 19, 2026, Organon announced the FDA approval of a supplemental New Drug Application extending the duration of use for the etonogestrel implant (Nexplanon) from 3 years to up to 5 years for the prevention of pregnancy. Based on a multicenter study of 399 women showing no pregnancies and a Pearl Index of 0.0 during years 4 and 5, the approval also includes data supporting efficacy across a BMI range of 17.2 to 64.3 kg/m². The updated labeling is accompanied by a new Risk Evaluation and Mitigation Strategy (REMS) program designed to ensure standardized provider training for proper insertion and removal.

Click here for our full coverage.

Aviva to advance, announce new data for AVA-291 women's testosterone therapy

On January 26, 2026, Aviva Bio announced the receipt of formal FDA feedback following a Type B meeting regarding development requirements for AVA-291 (d3-testosterone), a next-generation therapy engineered to resist aromatization. Based on preclinical data to be presented at the AACR Annual Meeting, AVA-291 demonstrated approximately 1000-fold less potential to stimulate breast cancer cell proliferation compared with ordinary testosterone. This milestone establishes a regulatory path for a female-specific androgen therapy designed to address unmet needs in menopause and perimenopause while minimizing estrogen-related safety concerns.

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FDA approves changes to iPLEDGE REMS to reduce burden during use of isotretinoin

On February 10, 2026, the FDA approved significant updates to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) for isotretinoin to reduce administrative burdens for patients and providers while maintaining pregnancy prevention standards. Based on a revised regulatory framework, the changes allow for at-home pregnancy testing after the initial visit, eliminate the "19-day lockout" period for missed prescription pickups, and remove monthly counseling documentation requirements for patients who cannot become pregnant. These updates are scheduled to formally take effect 180 days after the announcement, with the FDA maintaining current enforcement discretion on testing sites in the interim.

“Prescribers should reinforce counseling throughout the course of treatment; however, monthly documentation of counseling in the REMS for patients who cannot get pregnant is no longer required,” the FDA stated.

Click here for the full article.

FDA updates labels on multiple menopausal hormone therapies

On February 12, 2026, the FDA announced approved labeling changes for 6 menopausal hormone therapy (HRT) products, including Prometrium, Divigel, and Bijuva, to clarify risk considerations for healthcare providers and patients. Based on a comprehensive scientific literature review initiated in November 2025, the agency removed risk statements regarding cardiovascular disease, breast cancer, and probable dementia from the drugs' prominent boxed warnings. These updates across systemic and topical estrogen and progestogen categories aim to facilitate better-informed clinical decision-making for the treatment of moderate to severe vasomotor symptoms, vaginal atrophy, and bone loss.

Click here for details for each HRT product.

Ultrasound AI receives De Novo clearance for predictive delivery date technology

On March 2, 2026, the FDA granted De Novo clearance to Ultrasound AI for its Delivery Date AI technology, a cloud-based Software as a Medical Device (SaMD) designed to predict a delivery date using standard ultrasound images. Based on data from the PAIR study involving over 1.1 million images, the final V4 model achieved an R^2 value of 0.92 for all births and a mean absolute error of 19.99 days for spontaneous preterm births. This adjunctive tool is intended to support clinical decision-making by providing automated, image-based insights that reduce the impact of inter-operator variability and improve dating accuracy in high-risk or late-entry prenatal care.

“This [clearance], to me, is super exciting, because, for one, we don't have a lot of tools that come up in pregnancy,” said Raquel Dardik, MD, Chief medical officer, Ultrasound AI; Clinical associate professor, OBGYN, Herbert Wertheim College of Medicine, in a video interview with Contemporary OB/GYN. “Oftentimes, we have something that can slightly improve how this looks or can slightly improve how this gets managed, but it is unusual to have something that can actually change the way we look at things on a clinical basis,” added Dardik.

Click here for full clearance details from the FDA.

FDA clears LiviWell's post-intercourse fluid absorption device to support vaginal health

On March 24, 2026, the FDA granted clearance to Livi, a novel polyurethane foam device designed to support vaginal health by absorbing semen and post-intercourse fluids. Based on clinical rationale that semen can disrupt vaginal pH and contribute to odor or discharge, the single-use device is engineered to absorb fluids in approximately 60 seconds and is labeled for use up to 15 minutes post-intercourse. This regulatory milestone establishes a new category in intimate care, with a commercial launch planned for May 2026 to provide a medical-grade solution for common sexual health concerns.

Click here for the full article.

What ob-gyns can expect in Q2 of 2026

Now it is time to look ahead into Q2 of 2026. We’ve outlined what will be a few months of exciting and pivotal coverage from the Contemporary OB/GYN team as we highlight regulatory updates, leading medical society meetings, and continue to speak with leading experts in the field of women’s health.

Click here for what to expect in the second quarter of 2026.