News|Articles|September 1, 2026

A recap of top FDA & regulatory news from August 2026

Take a look back at some of the top FDA and pipeline news in women's health from August 2026.

August delivered another active month of regulatory and pipeline news in women’s health. Below, catch up on some of the top headlines from the month, and click each link to read and watch anything you may have missed, including news in the contraception, urology, menopause, vaginal health, and postpartum depression spaces.

Jeffrey Jensen, MD, reacts to FDA approval of new contraception patch, Gwyn Lo

Published August 3, 2026, this expert video reaction featured Jeffrey Jensen, MD, MPH, professor of obstetrics and gynecology at Oregon Health & Science University, commenting on the FDA’s July 29, 2026, approval of norelgestromin and ethinyl estradiol transdermal system (Gwyn Lo; Viatris) as a once-weekly, low-estrogen combined hormonal contraceptive for women with a BMI below 30.1 Jensen welcomed the approval as an expansion of patient choice, noting that the patch’s reduction in synthetic estrogen is a step in the right direction, and that its Pearl Index of 4.14 (95% CI, 2.77 to 5.95) from the phase 3 Luminous Study (NCT05139121) aligns with how methods are currently evaluated in the US.1

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FDA clears Revi Extend implant for urgency urinary incontinence

On August 5, 2026, the FDA granted 510(k) clearance to Revi Extend (BlueWind Medical, Ltd), an updated version of the implantable tibial neuromodulation Revi System for the treatment of urgency urinary incontinence (UUI) in women, featuring an extended device lifespan of 15 years.2 The clearance was supported by 3-year data from the pivotal OASIS trial, which found that 79% of participants achieved a 50% or greater reduction in UUI episodes and 95% reported satisfaction with the therapy, with no device- or procedure-related serious adverse events reported through 36 months.2

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Phase 2 data: ABCL635 reduces frequency, severity of VMS symptoms

On August 10, positive top-line results were published from the phase 2 portion of AbCellera’s phase 1/2 trial evaluating ABCL635, an investigational neurokinin 3 receptor (NK3R) antagonist antibody for moderate-to-severe vasomotor symptoms (VMS) due to menopause.3 In the randomized, double-blind, placebo-controlled trial of 92 postmenopausal women, a single subcutaneous 600 mg dose of ABCL635 produced a mean placebo-adjusted reduction in moderate-to-severe VMS frequency of 5.3 events per day at week 4 (P < 0.001), representing an 83% reduction vs 33% for placebo, with no serious adverse events reported.3

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FDA-cleared, post-intercourse vaginal health device launches

On August 18, 2026, Livi (LiviWell Inc.), the first FDA-cleared device designed to absorb semen and other post-intercourse fluids to support vaginal health, launched.4 The single-use, soft polyurethane foam device — cleared by the FDA on March 24, 2026, and commercially available as of August 18, 2026 — is inserted vaginally using a tampon-style applicator after intercourse, absorbs fluids in approximately 60 seconds, and may be used for up to 15 minutes post-intercourse, addressing pH disruption from semen that can contribute to bacterial vaginosis.4

Click here for full details.

Report: Postpartum depression market expected to grow based on awareness, pipeline progress

Published August 25, 2026, this article covered a market analysis from DelveInsight Business Research that projected growth in the postpartum depression (PPD) treatment market through 2036 across 7 major markets, with approximately 1.3 million diagnosed prevalent PPD cases reported across those markets in 2025.5 With brexanolone withdrawn in 2025, zuranolone (Zurzuvae; Sage/Biogen) currently leads the PPD treatment landscape, while investigational candidates luvesilocin and LPCN 1154 continue to advance in clinical trials, pointing to a broadening pipeline ahead.5

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New: Special Report on PMOS

September 1 marks the start of Polyendocrine Metabolic Ovarian Syndrome (PMOS) Awareness Month, previously PCOS Awareness Month. Contemporary OB/GYN convened a group of experts to discuss the May 2026 name change in a 5-part series.

Across the series, our host and experts examine what this shift means for diagnosis, management, and patient care across the reproductive lifespan.

Click here to view the series.

References:

  1. Jeffrey Jensen, MD, reacts to FDA approval of new contraception patch, Gwyn Lo. Contemporary OB/GYN. Published August 3, 2026. Accessed September 1, 2026. https://www.contemporaryobgyn.net/view/jeffrey-jensen-md-reacts-fda-approval-contraception-gwyn-lo
  2. FDA clears Revi Extend implant for urgency urinary incontinence. Contemporary OB/GYN. Published August 5, 2026. Accessed September 1, 2026. https://www.contemporaryobgyn.net/view/fda-clears-revi-extend-bluewind-medical-urgency-urinary-incontinence
  3. Phase 2 data: ABCL635 reduces frequency, severity of VMS symptoms. Contemporary OB/GYN. Published August 10, 2026. Accessed September 1, 2026. https://www.contemporaryobgyn.net/view/phase-2-data-abcl635-reduces-frequency-severity-vms-symptoms
  4. FDA-cleared, post-intercourse vaginal health device launches. Contemporary OB/GYN. Published August 19, 2026. Accessed September 1, 2026. https://www.contemporaryobgyn.net/view/livi-fda-cleared-post-intercourse-vaginal-device-launches
  5. Report: Postpartum depression market expected to grow based on awareness, pipeline progress. Contemporary OB/GYN. Published August 25, 2026. Accessed September 1, 2026. https://www.contemporaryobgyn.net/view/postpartum-depression-market-growth-pipeline-awareness-2036