Drug Pipeline News

The FDA office of Women's Health and Center for Drug Evaluation and Research and hosting a public workshop with a focus on testosterone use in menopausal women.

FDA accepted for review an sNDA for MIUDELLA copper IUD for a 6-year duration, with a PDUFA date in Q2 2027.

Get caught up with Contemporary OB/GYN! This list helps you navigate our top stories from the week, all in one place.

Atogepant reduced perimenstrual migraine days vs. placebo and met all 8 secondary endpoints in the Phase 3 LUNA study.

Get caught up with Contemporary OB/GYN! This list helps you navigate our top stories from the week, all in one place.

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

Livi was cleared by the FDA on March 24, 2026 as a novel device to support vaginal health.

AbCellera's ABCL635 met primary efficacy endpoints in a Phase 2 trial for moderate-to-severe hot flashes.

Get caught up with Contemporary OB/GYN! This list helps you navigate our top stories from the week, all in one place.

The FDA has cleared the Revi Extend, furthering the system's lifespan to 15 years to treat UUI.

Spring Fertility launched the Personalized IVF Calculator built on 2M+ data points from 25,000+ cycles.

FDA approved norelgestromin and ethinyl estradiol (Gwyn Lo; Viatris) as a low-dose once-weekly contraceptive patch.

Natural Cycles received a sixth FDA clearance for an updated version of its fertility-tracking algorithm.

Get caught up with Contemporary OB/GYN! This list helps you navigate our top stories from the week, all in one place.

Roche's cobas BV/CV assay received FDA clearance as a single-swab test for bacterial vaginosis and candida vaginitis.

Connor Frey, MD, explains why semaglutide and tirzepatide, but not liraglutide, generated menstrual adverse event signals in a FAERS pharmacovigilance analysis.

Get caught up with Contemporary OB/GYN! This list helps you navigate our top stories from the week, all in one place.

A reader-driven look at the 10 most-viewed articles on Contemporary OB/GYN from the first half of 2026, spanning FDA decisions, clinical research, and emerging treatments across menopause, contraception, endometriosis, and pelvic health.

A recap of the top FDA news stories covered by Contemporary OB/GYN in Q2 2026, spanning cervical cancer screening, menopause therapeutics, and antibiotic treatment for urinary tract infections.

A look ahead to the second half of 2026 for ob-gyns, including Viatris's pending FDA decision on a low-dose estrogen contraceptive patch and previews of the IDSOG, AUGS PFD Week, and The Menopause Society annual meetings.

Originally approved in February 2020, levonorgestrel and ethinyl estradiol has now received FDA approval for an updated labeled strength expected to appear on the market in the fall of 2026.

In part 2 of our discussion with Fiona Baker, PhD, she details how to interpret data from the NIRVANA study, which revealed reductions in wakefulness after sleep onset in the elinzanetant group vs placebo.

Backed by phase 3 data showing an overall success rate of 58.5% versus 60.2% for IV imipenem-cilastatin, tebipenem HBr has been approved by the FDA as the first oral carbapenem antibiotic for the treatment of complicated urinary tract infections in the US.

The FDA has approved Wockhardt’s cefepime and zidebactam, a novel intravenous antibiotic that targets multiple penicillin-binding proteins to treat adults with complicated urinary tract infections.

During clinical validation done by the company, Unity Confirm demonstrated 100% concordance with known fetal outcomes and invasive diagnostic results in 16 samples.