Drug Pipeline News

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.

In the 52-week OASIS-3 trial, elinzanetant significantly reduced the frequency and severity of hot flashes and night sweats.

Findings from the OASIS-3 trial show the nonhormonal drug elinzanetant cut vasomotor symptoms by 73%.

FDA accepts priority review of gepotidacin, a first-in-class oral antibiotic, for treating uncomplicated urogenital gonorrhea in patients 12 years and older.

Take a quick look at everything you may have missed last month, including the latest FDA updates, top stories, and exclusive interviews.

"The FDA did not raise any concern regarding the general approvability of elinzanetant in its correspondence," according to an anouncement from Bayer.

The FDA has granted priority review to expand flibanserin (Addyi; Sprout Pharmaceuticals) use to postmenopausal women, potentially broadening access to treatment for hypoactive sexual desire disorder.

Experts urge the FDA to update outdated warnings on menopausal hormone therapies, emphasizing the safety and benefits of low-dose vaginal estrogen.

DiaMedica Therapeutics' investigational therapy DM199 significantly reduced blood pressure and improved uterine blood flow in patients with preeclampsia, with a favorable safety profile.

A roundup of the most impactful FDA approvals in women’s health from January through June 2025, spanning diagnostics, therapeutics, and at-home care.

Oral sulopenem (ORLYNVAH; Iterum Therapeutics) was non-inferior to amoxicillin/clavulanate for treating uUTIs in women, per the phase 3 REASSURE trial.

As strains of antibiotic-resistant gonorrhea spread, zoliflodacin provides an alternative oral treatment with non-inferiority to other methods.

GSK and Spero Therapeutics announced that the phase 3 PIVOT-PO trial for tebipenem HBr, a potential first oral carbapenem for cUTIs in the United States, was stopped early because of positive efficacy results.

A novel oral antibiotic, gepotidacin (Blujepa; GSK), has demonstrated its effectiveness in treating uncomplicated urogenital gonorrhea, according to the results of a recent phase 3 clinical trial.

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

The approval marks a vital step toward care for urinary tract infections, helping to reduce recurrence and improve patients’ quality of life.

Ryan Haumschild, PharmD, MS, MBA, CPEL, explains the impact recently FDA-approved gepotidacin will have on uncomplicated UTIs and what this means in terms of antibiotic stewardship.

BlueWind Medical’s Revi System shows strong two-year efficacy and safety for UUI, with symptom reduction and high patient satisfaction.

Gameto’s Fertilo gets FDA clearance for a phase 3 trial, pioneering iPSC-based fertility treatment to shorten IVF cycles and improve reproductive care.