Drug Pipeline News

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).

PH80 nasal spray shows promise in reducing menopausal hot flashes, offering an effective and safe non-hormonal treatment option.

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 advisory committee meeting will discuss the potential approval of oral sulopenem etzadroxil/probenecid tablets for treating urinary tract infections in women aged 18 years and older.

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.

Astellas Pharma has announced the first dose administration of fezolinetant to manage moderate to severe vasomotor symptoms in breast cancer patients using adjuvant endocrine therapy.

In a recent study published in The Journal of Sexual Medicine, Sildenafil Cream, 3.6% was indicated as safe and well-tolerated for use against female sexual arousal disorder in healthy premenopausal women.

The investigational drug could prevent the rare fetal disease HDFN (hemolytic disease of the fetus and newborn) by stopping harmful antibodies from transferring through the placenta during pregnancy.

The over-the-counter, at-home test provides blood results in 15 minutes that could help result in sooner syphilis diagnoses.

A year after zuranolone’s FDA approval for postpartum depression on August 3, 2023, prescribers and a patient weigh in about the medication’s success in alleviating symptoms.

Bayer has submitted a New Drug Application for elinzanetant, following positive results from the OASIS studies, showing significant safety and efficacy in treating moderate-to-severe vasomotor symptoms in menopausal women.

These results indicated a significant reduction of CPP from 12 weeks of ZY5301 treatment. Investigators recommended a ZY5301 600 mg/d dose be investigated in a phase 3 trial.

Femlyv, containing norethindrone acetate and ethinyl estradiol, offers a new oral contraceptive option for individuals with swallowing difficulties, expanding access and convenience.