2025 has brought several pivotal FDA approvals that are expanding access to care, advancing diagnostic accuracy, and addressing long-standing gaps in women’s health.

From the first-in-class oral antibiotic gepotidacin for UTIs to AI-assisted fetal anomaly detection and at-home tools for STI and cervical cancer screening, these innovations reflect a growing shift toward personalized, accessible, and preventive care. Each approval highlights how regulatory progress is helping clinicians deliver faster diagnoses and more effective treatments for women across the reproductive lifespan.

In this recap, Contemporary OB/GYN reviews the most impactful FDA authorizations that shaped clinical practice in 2025.

2025 regulatory updates in ob-gyn

FDA approves gepotidacin for uncomplicated UTI treatment

The FDA approved gepotidacin (Blujepa; GSK) for the treatment of uncomplicated urinary tract infections (uUTIs) in female patients aged 12 years and older on March 25, 2025, marking the first oral antibiotic in a new class in over 20 years. Clinical trials demonstrated its superiority over nitrofurantoin, with higher therapeutic success rates and a lower potential for resistance development.

FDA approves Visby’s test for at-home STI identification

The FDA granted marketing authorization for the Visby Medical Women’s Sexual Health Test on March 28, 2025, making it the first at-home, prescription-free test for chlamydia, gonorrhea, and trichomoniasis. Designed for symptomatic and asymptomatic female patients, the test delivers results within approximately 30 minutes through the Visby Medical App.

FDA clears Sonio Suspect AI for fetal anomaly detection

The FDA cleared the Sonio Suspect AI model for detecting fetal anomalies on February 24, 2025, offering a 22-point improvement in reader performance and enhancing early and accurate diagnoses. The technology integrates real-time AI quality control with anomaly detection, addressing gaps in prenatal ultrasound screenings, where up to 51% of anomalies go undetected.

FDA approves Teal Wand for at-home cervical cancer screening

The FDA approved the Teal Wand on May 9, 2025, as the first at-home vaginal self-collection device for cervical cancer screening in U.S. women. Designed for women aged 25 to 65 at average risk, the device demonstrated 96% accuracy in identifying cervical precancer in the SELF-CERV trial and showed strong user preference and ease of use. The Teal Wand offers a comfortable alternative to traditional Pap smears and may help increase screening rates, especially among underserved populations. Nationwide availability is expected to follow its June launch in California, with insurance support aimed at reducing access barriers.

FDA approves generic mifepristone tablet for abortion

The FDA approved a generic version of mifepristone tablets, 200 mg, submitted by Evita Solutions, LLC, on October 2, 2025, under an abbreviated new drug application, confirming bioequivalence and therapeutic equivalence to Mifeprex (Danco Laboratories). Mifepristone, used in combination with misoprostol, is indicated for the medical termination of intrauterine pregnancy through 70 days of gestation.

FDA approves elinzanetant (Lynkuet) for vasomotor menopausal symptoms

The FDA approved elinzanetant 60 mg capsules (Lynkuet; Bayer) on October 24, 2025, for the treatment of moderate to severe hot flashes associated with menopause, based on data from the phase 3 OASIS clinical program. The approval makes elinzanetant the first FDA-approved dual neurokinin 1 and neurokinin 3 receptor antagonist for vasomotor symptoms, providing a new nonhormonal treatment option for menopausal women, including those with contraindications to estrogen therapy.

FDA approves fosfomycin for treating cUTIs

The FDA approved fosfomycin injection (Contepo; Meitheal Pharmaceuticals) for the treatment of complicated urinary tract infections, including acute pyelonephritis, in adults aged 18 years and older, expanding treatment options for serious UTIs caused by resistant pathogens. Fosfomycin has no known cross-resistance with other antibiotic classes and is active against common gram-negative organisms such as Escherichia coli and Klebsiella pneumoniae.

FDA approves gepotidacin (Blujepa) oral therapy for uncomplicated urogenital gonorrhea

The FDA approved a supplemental new drug application for gepotidacin (Blujepa; GSK) as an oral treatment for uncomplicated urogenital gonorrhea in patients aged 12 years and older weighing at least 45 kg who have limited or no alternative treatment options. The approval marks the first new oral antibiotic class for gonorrhea in more than three decades and provides a noninjectable alternative to standard intramuscular therapy, addressing a major unmet need amid rising antimicrobial resistance.

FDA approves zoliflodacin (Nuzolvence) for uncomplicated gonorrhea

The FDA approved Nuzolvence (zoliflodacin; Innoviva Specialty Therapeutics) as a single-dose oral treatment for uncomplicated urogenital gonorrhea in adults and pediatric patients aged 12 years and older who weigh at least 35 kg. The approval marks one of the first new treatment options for gonorrhea in nearly two decades and provides a convenient, noninjectable alternative to standard therapy at a time of rising antimicrobial resistance.

FDA approves expanded use of flibanserin for hypoactive sexual desire disorder in women

The FDA approved Addyi (flibanserin 100 mg) for the treatment of hypoactive sexual desire disorder (HSDD) in women younger than 65 years, expanding its indication to include postmenopausal patients for the first time. The decision makes Addyi the first FDA-approved, nonhormonal pharmacologic therapy specifically available to both premenopausal and postmenopausal women with HSDD, a common and historically undertreated condition characterized by persistent, distressing low sexual desire.

FDA grants 510(k) clearance to Revi System against urgency urinary incontinence

The FDA granted 510(k) clearance to the Revi System (BlueWind Medical) for the long-term management of urgency urinary incontinence (UUI), authorizing use of the wearable, implantable tibial neuromodulation device with updated, patient-friendly controls. The system is designed to provide adjustable therapy through a minimally invasive, single-procedure implant performed under local anesthesia, without the need for a trial phase.

FDA clears FemVue Controlled for in-office tubal assessment

The FDA granted 510(k) clearance to the FemVue Controlled device (Femasys Inc.) for assessing fallopian tube status, authorizing its use for in-office screening of tubal infertility using controlled ultrasound contrast delivery. The updated device integrates FemVue and FemChec technologies, allowing clinicians to alternate saline and air contrast during ultrasound imaging without radiation exposure or iodinated contrast, and to provide results within approximately 10 to 15 minutes.