Drug Pipeline News

A single subcutaneous dose of RE104 produced rapid and durable improvements in postpartum depression, supporting advancement into phase 3 development.

The extended approval and contracpetive efficacy during use from 3 to 5 years was based on a multicenter, single-arm, open-label study (NCT04626596) conducted in the United States.

A large systematic review and meta-analysis found no evidence that paracetamol use during pregnancy increases the risk of autism, ADHD, or intellectual disability in children.

A phase 3 trial of oral brexanolone for postpartum depression will continue unchanged following a favorable DSMB safety review.

Screen-guided care using the PreTRM blood test reduced preterm birth–related complications and NICU use.

Check out the biggest approvals in women's health during 2025.

Recent FDA approvals and emerging research highlight how neurokinin receptor antagonists are expanding nonhormonal options for managing vasomotor symptoms.

GSK, Spero Therapeutics, resubmitted an NDA for tebipenem HBr, an oral carbapenem antibiotic, for treating complicated UTIs, supported by phase 3 trial data.

The updated Revi System streamlines management of urgency urinary incontinence, with an easy-to-use design and a strong body of clinical evidence.

The FDA approved flibanserin for HSDD in women younger than 65 years, expanding access to the first nonhormonal therapy for low sexual desire.

Edward Hook, MD, discusses the FDA approval of oral zoliflodacin and its role in expanding treatment options for uncomplicated gonorrhea amid rising resistance.

The FDA has approved Nuzolvence as a new single-dose oral option for uncomplicated urogenital gonorrhea in adults and children 12 years and older who weigh at least 77 lb.

George L. Maxwell, MD, outlines the SUNFLOWER phase 3 trial assessing Mirena vs oral progestin for treating nonatypical endometrial hyperplasia.

Phase 3 results show oral zoliflodacin was non-inferior to ceftriaxone and azithromycin for uncomplicated urogenital gonorrhea.

This approval of gepotidacin is the first in a new antibiotic class for the treatment of gonorrhoea approved in over 3 decades.

A phase 2 trial found the maternal GBS-AlpN vaccine to be immunogenic and have an acceptable safety profile in pregnant women and their infants.

DARE to PLAY sildenafil cream is now available for prescribing in select states as a non-hormonal topical option to improve genital blood flow and arousal.

A review found that indocyanine green performs similarly to technetium-99m and blue dye in identifying vulvar cancer.

Review some of the top stories from the Contemporary OB/GYN website over the past week and catch up on anything you may have missed.

The FDA’s investigational device exemption approval allows FemBloc to enter the final phase of its pivotal trial.

The FDA has approved injectable fosfomycin for adults with complicated urinary tract infections, offering a new treatment option against multidrug-resistant bacteria.

Zoliflodacin study investigator Sarah McLeod, PhD, highlights data presented at IDWeek 2025 in a Q&A.

Following positive safety and efficacy data, the FDA has approved elinzanetant to manage vasomotor symptoms in postmenopausal women.

Tebipenem HBr met primary endpoints in a phase 3 trial, showing oral efficacy comparable to IV carbapenem for complicated urinary tract infections.

On October 2, 2025, the FDA approved a generic version of mifepristone to be used in a regimen with misoprostol for abortion.