Women's Health

FDA Rejects Treatment for Uterine Fibroids Based on Safety Concerns

By August 22, 2018

The NDA included data from two Phase 3 clinical trials (VENUS I and VENUS II), all four Phase 3 European Union registration studies, and real-world data of >700,000 women with uterine fibroids across 80 countries.

Preservative-Free, Generic Version of Makena Now Available

By June 28, 2018

Hydroxyprogesterone Caproate is used to lower the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

FDA Warns Against Using Stolen Fertility Drugs

By May 31, 2018

Healthcare professionals and patients should check Gonal-f products for possible tampering before use; purchases should only be made through licensed wholesale distributors and pharmacies.

Imvexxy Approved for Moderate to Severe Dyspareunia Due to Menopause

By May 30, 2018

The FDA approval was supported by findings from a Phase 3, randomized, double-blind, placebo-controlled study that evaluated Imvexxy (4mcg and 10mcg) vs placebo from baseline to week 12.

First Single-Dose Oral Therapy for Bacterial Vaginosis Launched

By May 29, 2018

In both pivotal trials, a statistically significant greater percentage of treatment patients experienced clinical response vs those treated with placebo at 21 to 30 days following a single dose.

HPV Vaccination May Offer Protection Against Cervical Precancer

By May 11, 2018

The authors concluded, "There is high-certainty evidence that HPV vaccines protect against cervical precancer in adolescent girls and young women aged 15 to 26," while also indicated that future studies should have long-term follow-up.

Bremelanotide NDA Submitted to FDA for Hypoactive Sexual Desire Disorder

By March 26, 2018

Bremelanotide is used as needed prior to anticipated sexual activity.

Progestin-Only Contraceptives and Depression: Is There a Link?

By February 28, 2018

Study quality was graded according to the United States Preventive Services Task Force and the Cochrane Risk of Bias Tools.

Verzenio Gains Expanded Breast Cancer Indication

By February 27, 2018

The approval of Verzenio as initial therapy in combination with an aromatase inhibitor is based on the efficacy and safety demonstrated in the pivotal MONARCH 3 clinical trial.

Drug-Free Supplements Launched for Menopause Symptom Relief

By December 15, 2017

The drug-free supplements also contain varying levels of flax, vitamin B2, vitamin B6, D-biotin, and vitamin D3.

Elagolix NDA Submitted for Treating Endometriosis-Associated Pain

By September 06, 2017

Elagolix, an oral gonadotropin-releasing hormone (GnRH) antagonist, was evaluated in two Phase 3 clinical studies in about 1,700 women with moderate-to-severe endometriosis-associated pain.

Liletta Approved to Prevent Pregnancy for up to Four Years

By August 07, 2017

The FDA's approval of the supplemental New Drug Application (sNDA) was based on efficacy and safety data from the ongoing Phase 3 ACCESS IUS trial.

Efficacy of Treatments Compared for Female Pattern Hair Loss

By June 07, 2016

The safety and efficacy of topical minoxidil for the treatment of female pattern hair loss was supported by moderate to low quality evidence in a recent Cochrane systematic review.