Drug Pipeline News

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Experts urge the FDA to update outdated warnings on menopausal hormone therapies, emphasizing the safety and benefits of low-dose vaginal estrogen.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

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.

Vvax001, a new HPV16 vaccine, offers a potential alternative to surgery for treating precancerous cervical lesions, with promising trial results.

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 OASIS 4 clinical trial showed successful reductions in the frequency and severity of hot flashes caused by adjuvant endocrine therapy used in breast cancer management.

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.

Study shows sildenafil cream 3.6% improves sexual arousal in diverse women with FSAD, offering hope for millions seeking effective treatment.

Iterum Therapeutics has announced the FDA has approved ORLYNVAH (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs)

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.

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.

Sanofi’s influenza vaccine has received an updated label to include adult pregnant women following a trial indicating similar safety outcomes to standard influenza vaccination in this population.

Reunion Neuroscience is enrolling patients in its phase 2 RECONNECT trial to assess a single-dose synthetic psychedelic to treat the depressive symptoms of PPD.

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 New Drug Application (NDA) acceptance is supported by positive data from 3 clinical trials (OASIS 1, 2, and 3).