In the article below, we get you set for 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.

First, a quick look back on some key FDA-related news that Contemporary OB/GYN covered:

EUROGIN: Merck's 9-valent HPV vaccine provides protection at least 14 years

Long-term follow-up data from a pivotal clinical efficacy trial indicate that Merck’s 9-valent human papillomavirus (9vHPV) vaccine, GARDASIL 9, provides sustained protection against high-grade cervical disease for more than a decade after administration. The results, which tracked vaccinated women for up to 15.6 years, demonstrate that the vaccine’s effectiveness remains exceptionally high without evidence of significant waning immunity over time.

Read full findings here.

FDA clears ENDO-205 Investigational New Drug application for endometriosis

An Investigational New Drug (IND) application for ENDO-205 (EndoCyclic Therapeutics), a first-in-class, non-hormonal targeted peptide therapeutic for endometriosis, has been cleared by the FDA, according to a press release from EndoCyclic Therapeutics on March 23, 2026. The company is planning to initiate a phase 1 clinical study among healthy women in the pre-menopausal age who are of reproductive age.

The World Health Organization (WHO), among many other medical societies, acknowledges that access to early diagnosis and effective treatment is limited, especially in low- and middle-income countries.

Read our complete coverage, here.

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

The FDA granted clearance on March 24, 2026, to Livi, a novel device designed to support vaginal health by absorbing semen and other post-intercourse fluids. The device was designed to prevent the pH disruption caused by semen, which can lead to odor and symptoms associated with bacterial vaginosis.

Find out more here.

Regulatory decisions

Doravirine/islatravir [DOR/ISL (100 mg/0.25 mg), (MK-8591A)] (Merck)

PDUFA: April 28, 2026

Indication: Adults with HIV-1

On February 25, 2026, Merck announced pivotal phase 3 trial results for its investigational, once-daily oral regimen of doravirine/islatravir (DOR/ISL), positioned to meet the evolving needs of people living with HIV-1.¹

The FDA has set a PDUFA date of April 28, 2026, for potential approval of the new drug application in virologically suppressed adults. If approved by this April deadline, DOR/ISL would become the first 2-drug, non-integrase strand transfer inhibitor (non-INSTI) regimen in Merck’s portfolio.

The phase 3 MK-8591A-053 trial compared DOR/ISL to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in treatment-naïve adults. The study met its primary endpoint, with 91.8% of the DOR/ISL group achieving viral suppression (HIV-1 RNA <50 copies/mL) compared to 90.6% for BIC/FTC/TAF at Week 48 (treatment difference 1.2%, 95% CI: -3.7, 6.2, P < .001).

“These new phase 3 results are meaningful, showing that an investigational 2-drug regimen without an INSTI demonstrated non-inferior efficacy and a comparable safety profile versus BIC/FTC/TAF in previously untreated adults with HIV-1, including those with advanced disease,” said Jürgen K. Rockstroh, MD, professor of medicine at the University of Bonn, in a statement. “This study evaluated a diverse, global population, and included a significant proportion of participants with high viral loads and low CD4 counts. These findings add to the growing evidence supporting the potential role of DOR/ISL in HIV care.”

Tebipenem HBr

PDUFA: June 18, 2026

Indication: Complicated urinary tract infections (cUTI), including pyelonephritis

This investigational oral carbapenem antibiotic from Spero Therapeutics and licensed for commercialization by GSK, is in development to treat cUTI, including pyelonephritis, to provde and oral therapeutic alternative to IV carbapenems, according to a press release from Spero.²

The NDA was resubmitted to the FDA in December 2025, with the PDUFA announced in February 2026. Supporting the application were findings from the phase 3 PIVOT-PO trial. According to Spero, the trial “demonstrated non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin in hospitalized patients with cUTI, including pyelonephritis, based on the overall response (composite of clinical cure plus microbiological eradication of the bacteria causing the infection) at the test of cure visit.”

“2025 was marked by important progress across the tebipenem HBr program in cUTI, including completion of the global phase 3 trial and resubmission of the NDA,” said Esther Rajavelu, President and CEO of Spero. “With our licensing partner GSK’s global leadership in anti-infectives, tebipenem HBr, if approved, has the potential to address an important need and meaningfully improve treatment options for patients with cUTI. We look forward to the FDA’s decision in late June as we continue to execute our business strategy to deliver innovative therapies.”

Conferences

Meeting: 2026 American College of Obstetricians & Gynecologists (ACOG) Annual Clinical & Scientific Meeting

Dates: May 1-3, 2026

Location: Washington, DC

Summary: This year’s annual gathering from ACOG is set to include “sessions in 6 new focus areas and 3 certificate tracks,” according to the organization. Among the noteworthy names for this year’s meeting are former First Lady Michelle Obama, who will participate in a moderated conversation on May 2.

Other program elements to watch for at this year’s meeting include³:

• ACOG: The Latest and Greatest Guidance Updates – Experts will discuss updates on Postmenopausal Bleeding Evaluation, Cervical Cancer Screening, and Screening for Fetal Chromosomal Abnormalities.
• The Morton and Diane Stenchever Lecture: Reproductive Transitions in Midlife - Evidence-Based Management from Contraception into Perimenopause and Menopause – Rajita Patil, MD, of UCLA Health, will speak on “nuanced clinical presentation and management of perimenopause in patients aged 35–50” (https://www.abstractsonline.com/pp8/#!/21317/session/241).
• Delivering Person-Centered Menopause Care: Integrating Diverse Models Across Gynecologic Encounters – As menopause care continues to be at the forefront of women’s health discourse, this session seeks to “equip OB/GYNs with practical strategies to initiate and navigate menopause-related discussions across a range of gynecologic visit types, including annual preventive care and problem-focused encounters” (https://www.abstractsonline.com/pp8/#!/21317/session/265)
• The Donald F. Richardson Memorial Lecture: Menopause and Sexual Health – Another menopause-related presentation will come from Pelin Batur, MD, of Cleveland Clinic, who will touch on genitourinary syndrome of menopause, hypoactive sexual desire disorder, and more.
• Three P’s: Patient, Preparation and Performance Building Surgical Confidence in the Surgical Management of Endometriosis – Coming closely on the heels of new ACOG guidance on endometriosis, this session will see Trina VH Mansour, MD, of Phoenix VA Healthcare System and Megan Nicole Wasson, DO, of Mayo Clinic in Phoenix offer “critical insights into pre-operative evaluation along with intra-operative considerations for safe surgical excision” (https://www.abstractsonline.com/pp8/#!/21317/session/35)
• Targeting Obesity: The Role of GLP-1 Receptor Agonists, Hormones, Gut Microbiome, and Sarcopenia Prevention – As GLP-1s continue to occupy headlines and airwaves, this session will feature Johanna Finkle, MD, along with Lindsay Raye Nordwald, MD, both of the University of Kansas Medical Center, for a deep dive on these hotly-debated medications and their implications for treating obesity in women.

Meeting: Sleep 2026

Dates: June 14-17, 2026

Location: Baltimore, Maryland

Summary: This American Academy of Sleep Medicine/Sleep Research Society joint venture includes several program offerings related to sleep medicine in pregnant or menopausal women.⁴

The meeting will be the society’s 40th annual for the Associated Professional Sleep Societies, which will bring “together the world’s leading experts offering unparalleled opportunities for knowledge sharing, networking, and discovering advances in clinical sleep medicine, sleep and circadian research, and sleep health.”

The featured keynote speaker will be Carlos Schenck, MD, a psychiatrist and sleep researcher who co-discovered REM sleep behavior disorder (RBD) and its connection to future Parkinsonism. A senior psychiatrist at Hennepin County Medical Center in Minneapolis, MN, he has earned top honors from the AASM, SRS, and AAN, founded the International RBD Study Group, and contributed extensively to multiple editions of the International Classification of Sleep Disorders, according to the meeting’s homepage.

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References:

1. Merck announces late-breaking data from three phase 3 trials evaluating Doravirine/Islatravir (DOR/ISL), an investigational, once-daily, two-drug regimen for the treatment of adults living with HIV-1 at CROI 2026. Merck. Press release. February 25, 2026. Accessed March 27, 2026. https://www.merck.com/news/merck-announces-late-breaking-data-from-three-phase-3-trials-evaluating-doravirine-islatravir-dor-isl-an-investigational-once-daily-two-drug-regimen-for-the-treatment-of-adults-living-with-hiv-1/
2. Spero Therapeutics announces fourth quarter and full year 2025 operating results and provides a business update. March 27, 2026. Accessed March 27, 2026. https://www.biospace.com/press-releases/spero-therapeutics-announces-fourth-quarter-and-full-year-2025-operating-results-and-provides-a-business-update
3. Registration. American College of Obstetricians & Gynecologists. Accessed March 27, 2026. https://annualmeeting.acog.org/registration/
4. SLEEP 2026. Baltimore, MD | June 14-17, 2026. Accessed March 27, 2026. https://www.sleepmeeting.org/