As we close out 2025, the fourth quarter (Q4) has delivered major advancements across menopause care, cervical cancer screening, infectious disease management, and preventive women’s health.

From FDA approvals and clinical trial breakthroughs to evolving screening technologies and expert insights on disparities and lifestyle interventions, these developments reflect the ongoing innovation in gynecologic care.

In this Q4 recap, Contemporary OB/GYN highlights the most impactful regulatory decisions, research findings, and expert commentary that shaped women’s health in 2025.

Click on each title below for full coverage and clinical insights.

Q4 2025 regulatory updates in ob-gyn

FDA approves elinzanetant (Lynkuet) for vasomotor menopausal symptoms

The FDA has approved elinzanetant 60 mg capsules (Lynkuet; Bayer) for the treatment of moderate to severe vasomotor symptoms due to menopause, marking the first FDA-approved dual neurokinin-1 and neurokinin-3 receptor antagonist for this indication. The decision was supported by phase 3 data from the OASIS program, including OASIS-3, in which elinzanetant reduced hot flash frequency and severity by more than 73% at 12 weeks compared with 47% for placebo, with additional improvements in sleep disturbance and menopause-specific quality of life. Safety findings were consistent across trials, with no treatment-related serious adverse events reported, supporting elinzanetant as a new nonhormonal option for patients with contraindications to estrogen therapy.

DARE to PLAY sildenafil cream becomes commercially available for women in select states

Daré Bioscience has announced commercial availability of DARE to PLAY, a topical sildenafil cream developed for women, offered initially in select US states through a Section 503B outsourcing facility. The nonhormonal formulation is designed to locally increase genital blood flow and enhance arousal sensations, with onset reported within 10 to 15 minutes in clinical studies, addressing a longstanding gap in female sexual health therapeutics. Although compounded products are not FDA approved, the launch is supported by toxicology testing and randomized clinical trials, including a phase 2b study that identified meaningful improvements in sexual arousal and reduced distress among a subset of women with female sexual arousal disorder, while the company continues efforts toward full regulatory approval.

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

The FDA has approved a supplemental new drug application for gepotidacin (Blujepa; GSK) as an oral treatment for uncomplicated urogenital gonorrhea in adolescents and adults aged 12 years and older with limited or no alternative options. The decision was supported by phase 3 EAGLE-1 trial data demonstrating noninferior microbiological cure rates compared with injectable ceftriaxone plus azithromycin, with no treatment-related serious adverse events reported. The approval introduces the first new class of oral antibiotics for gonorrhea in more than 30 years and offers a noninjectable option amid rising antimicrobial resistance and the continued absence of a licensed gonorrhea vaccine in the United States.

Q4 2025 top headlines in ob-gyn

Zoliflodacin demonstrated non-inferiority in adults and adolescents with gonorrhea

Innoviva Specialty Therapeutics has announced publication of multicountry phase 3 trial results showing that investigational oral zoliflodacin was noninferior to standard ceftriaxone plus azithromycin for the treatment of uncomplicated urogenital gonorrhea in adolescents and adults. The findings, published in The Lancet, demonstrated comparable microbiological cure rates and safety profiles, including at extragenital sites, supporting zoliflodacin as a potential single-dose oral alternative amid rising antimicrobial resistance. The agent has received a Qualified Infectious Disease Product designation from the FDA, with regulatory review ongoing ahead of a December 2025 PDUFA target date, positioning zoliflodacin as a promising candidate to expand treatment options beyond injectable first-line therapy.

Maternal GBS vaccine (GBS-AlpN) shows immunogenicity and acceptable safety in phase 2 trial

A phase 2 randomized, placebo-controlled study found that the investigational maternal vaccine GBS-AlpN was immunogenic when administered during pregnancy and led to high concentrations of vaccine-specific antibodies in infants at birth, with an acceptable safety profile for both mothers and infants. Conducted across multiple countries, the trial showed that vaccinated groups achieved substantially higher cord blood IgG levels than placebo, supporting effective transplacental antibody transfer, while most maternal adverse events were mild to moderate and no infant deaths were considered vaccine related. Investigators concluded that the findings support advancement of GBS-AlpN into phase 3 trials as a potential strategy to reduce early- and late-onset neonatal group B streptococcal disease.

High rates of misdiagnosis reported among perimenopausal women

Nearly 40% of women seeking care for perimenopause symptoms report feeling misdiagnosed, according to a new survey from Biote, with many receiving diagnoses for anxiety or depression rather than care addressing underlying hormonal changes. The findings highlight limited provider engagement and gaps in menopause education, with fewer than half of respondents reporting that their clinician initiated discussions about perimenopause and many relying on nonmedical sources for information. Investigators noted that improved clinician education and earlier, accurate diagnosis—along with evidence-based interventions such as cognitive behavioral therapy—may help address unmet needs during perimenopause, particularly as awareness and regulatory shifts around hormone therapy continue to evolve.