We're officially at the halfway point of the year, and the past few months delivered a steady stream of regulatory news for ob-gyns to track. Below, the Contemporary OB/GYN team recaps some of the top FDA-related stories we covered this quarter, spanning cervical cancer screening, menopause therapeutics, and antibiotic treatment for urinary tract infections.

Top women’s health FDA news, Q2 2026

FDA clears Onclarity HPV self-collection kit, approves BD Onclarity HPV Assay for cervical cancer screening

On April 8, 2026, the FDA cleared Waters Corporation's Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay with extended genotyping for at-home use, expanding access to cervical cancer screening. The decision addresses the fact that approximately 60% of cervical cancer cases occur in individuals who are currently unscreened or under-screened. The kit will be available by prescription and covered by major insurers, including Medicare and Medicaid, with samples processed on the fully automated BD COR System.¹

Click here for full details.

FDA says "study may proceed" for Vistagen's refisolone nasal spray for vasomotor symptoms

On April 22, 2026, Vistagen received a "Study May Proceed" letter from the FDA, clearing the way for continued phase 2 development of refisolone, a non-hormonal, non-systemic intranasal candidate for moderate-to-severe menopausal vasomotor symptoms. In an earlier exploratory phase 2a trial, refisolone reduced hot flash frequency by 80% compared to 36% for placebo, with improvements observed as early as 1 week and no serious drug-related adverse events reported.²

Click here for full details.

FDA approves cefepime and zidebactam intravenous antibiotic to treat adults with cUTI

On June 1, 2026, the FDA approved cefepime and zidebactam (ZAYNICH; Wockhardt), a novel intravenous antibiotic that simultaneously targets multiple penicillin-binding proteins to treat adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens. In the phase 3 ENHANCE-1 trial, the combination achieved a composite clinical cure and microbiological response rate of 89%, compared to 68.4% for meropenem, a treatment difference of 20.6% (95% CI: 12.3, 29.5).³

Click here for full details.

FDA approves tebipenem pivoxil as first oral carbapenem antibiotic for complicated urinary tract infections

On June 17, 2026, the FDA approved tebipenem pivoxil (Utebzi; Spero Therapeutics/GSK), making it the first oral carbapenem antibiotic available in the US for complicated urinary tract infections, including pyelonephritis. The approval was supported by the phase 3 PIVOT-PO trial, which demonstrated non-inferiority to IV imipenem-cilastatin, with an overall success rate of 58.5% versus 60.2% (adjusted treatment difference of 1.3%; 95% CI: 7.5%, 4.8%).⁴

Click here for full details.

FDA: Levonorgestrel/ethinyl estradiol birth control patch sees update to labeled strength

On June 19, 2026, Exeltis USA announced FDA approval of an updated labeled strength for its levonorgestrel and ethinyl estradiol (TWIRLA) transdermal contraceptive system, a change intended to more accurately reflect the amount of hormone delivered to the user. The update is strength-labeling only, with no change to the product's formulation, composition, manufacturing process, or BMI-based prescribing limitations, and is expected to appear on the market in September or October 2026.⁵

Click here for full details.

Don't miss any updates from Contemporary OB/GYN

Thank you for filling out your details and reading with us! To keep in touch with the latest news for today's ob-gyn, consider subscribing to our free biweekly e-newsletter, which features our latest headlines, conference coverage, and expert video interviews.

Click here to sign up.

References:

1. FDA clears Onclarity HPV self-collection kit, approves BD Onclarity HPV Assay for cervical cancer screening. Contemporary OB/GYN. Published April 8, 2026. Accessed June 29, 2026. https://www.contemporaryobgyn.net/view/fda-clears-onclarity-hpv-self-collection-kit-approves-bd-onclarity-hpv-assay-cervical-cancer-screening
2. FDA says "study may proceed" for Vistagen's refisolone nasal spray for vasomotor symptoms. Contemporary OB/GYN. Published April 22, 2026. Accessed June 29, 2026. https://www.contemporaryobgyn.net/view/fda-says-study-may-proceed-for-vistagen-s-refisolone-nasal-spray-for-vasomotor-symptoms
3. FDA approves cefepime and zidebactam intravenous antibiotic to treat adults with cUTI. Contemporary OB/GYN. Published June 1, 2026. Accessed June 29, 2026. https://www.contemporaryobgyn.net/view/fda-approves-cefepime-and-zidebactam-intravenous-antibiotic-to-treat-adults-with-cuti
4. FDA approves tebipenem pivoxil as first oral carbapenem antibiotic for complicated urinary tract infections. Contemporary OB/GYN. Published June 17, 2026. Accessed June 29, 2026. https://www.contemporaryobgyn.net/view/fda-approves-tebipenem-pivoxil-first-oral-carbapenem-antibiotic-complicated-urinary-tract-infections
5. FDA: Levonorgestrel/ethinyl estradiol birth control patch sees update to labeled strength. Contemporary OB/GYN. Published June 19, 2026. Accessed June 29, 2026. https://www.contemporaryobgyn.net/view/fda-levonorgestrel-ethinyl-estradiol-birth-control-patch-sees-update-to-labeled-strength