COVID-19 Vaccination Linked to Small Increase in Menstrual Cycle Length
Data from the Natural Cycles app was analyzed for an association between COVID-19 vaccination menstrual cycle changes.
Obstetrics and Gynecology
Linzagolix Under Review for Treatment of Uterine Fibroids
Linzagolix is a novel, oral gonadotropin-releasing hormone (GnRH) receptor antagonist.
FDA Clears Updates to Jada System, a Device to Control Postpartum Hemorrhage
The Jada System is comprised of an intrauterine device that utilizes low level vacuum to induce normal contraction of the uterus.
Tivdak Approved for Recurrent or Metastatic Cervical Cancer
The approval was based on data from the phase 2 innovaTV 204 trial that evaluated Tivdak as monotherapy in 101 adult females with recurrent or metastatic cervical cancer.
Linzagolix NDA Submitted for Uterine Fibroid Treatment
The NDA submission is supported by data from the phase 3 PRIMROSE 1 and PRIMROSE 2 studies, along with data from the 76-week post-treatment follow-up study.
FDA to Review Relugolix Combination Therapy for Endometriosis Pain
The application is supported by data from the phase 3 SPIRIT program, which includes the SPIRIT 1 and SPIRIT 2 studies, as well as an open-label extension study.
Mirena Approved for Pregnancy Prevention for Up to 7 Years
By the end of the 7th year, Mirena should be removed and replaced at the time of removal with a new system if continued use is desired.
Clindamycin Vaginal Gel Gets Priority Review for Bacterial Vaginosis
The product is designed as a one-time vaginally administered treatment.
Oteseconazole Gets Priority Review for Recurrent Vulvovaginal Candidiasis
The NDA submission is supported by data from three phase 3 trials, which included 2 global studies and one US-focused study.
Novel Oral Contraceptive Nextstellis Now Available
The approval was based on data from two phase 3 studies that evaluated the safety, acceptability, efficacy, and cycle control of Nextstellis in 3725 women aged 16 to 50.
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