April 26th 2024
Gilead Sciences has announced FDA approval of an updated Biktarvy label, showcasing safety and efficacy data from a phase 1b trial, positioning it as a pivotal treatment option for pregnant individuals with HIV-1 and suppressed viral load.
23rd Annual International Congress on the Future of Breast Cancer® East
July 19-20, 2024
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Community Practice Connections™: 14th Annual International Symposium on Ovarian Cancer and Other Gynecologic Malignancies
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4th Annual International Congress on the Future of Women’s Health™
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Patient, Provider, and Caregiver Connection™: Exploring Unmet Needs In Postpartum Depression – Making the Case for Early Detection and Novel Treatments
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Identifying Health Care Inequities in Screening, Diagnosis, and Trial Access for Breast Cancer Care: Taking Action With Evidence-Based Solutions
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16th Annual International Symposium on Ovarian Cancer and Other Gynecologic Malignancies™
May 2025
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FDA turns down new drug application for oral UTI treatment
June 27th 2022The US Food & Drug Administration (FDA) sent a response letter to Spero Therapeutics regarding its New Drug Application (NDA) for tebipenem pivoxil hydrobromide (tebipenem HBr) to treat complicated UTIs, saying the application lacks sufficient data.
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Evofem Biosciences announces results of post hoc analysis of phase 3 clinical trial data
June 21st 2022Evofem Biosciences, Inc. recently announced results of a post hoc analysis of the registrational Phase 3 AMPOWER trial, which investigated the ability of a contraceptive gel consisting of lactic acid, citric acid, and potassium bitartrate (Phexxi; Evofem) to prevent pregnancy.
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Scynexis submits sNDA for expanded indication of ibrexafungerp tablets
June 8th 2022Currently approved for the treatment of vulvovaginal candidiasis (VVC), and if the sNDA is approved, ibrexafungerp (Brexafemme; Scynexis) would be the first and only oral non-azole medication for the prevention of recurrent VVC.
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FDA accepts Myfembree sNDA for bleeding associated with uterine fibroids
June 2nd 2022The US Food and Drug Administration has accepted to review the supplemental New Drug Application for Myfembree for the potential treatment of heavy menstrual bleeding associated with uterine fibroids for up to 2 years.
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Myfembree for moderate-to-severe endometriosis pain: Potential for adolescents
February 23rd 2022Contemporary OB/GYN® Associate Editor Lindsey Carr sat down with Jessica Shim, MD, an attending at in the Division of Gynecology, Department of Surgery, Boston Children’s Hospital; Harvard Medical School Boston, Massachusetts, to discuss Myfembree (relugolix, estradiol, and norethindrone acetate tablets; Myovant Sciences, Pfizer) and its possible approval in May 2022.
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Trastuzumab deruxtecan significantly improves PFS, OS in HER2-low metastatic breast cancer
February 22nd 2022Trastuzumab deruxtecan resulted in a statistically significant improvement in progression-free survival and overall survival compared with physician’s choice of chemotherapy in patients with HER2-low unresectable and/or metastatic breast cancer, irrespective of hormone receptor status, meeting the primary and secondary end points of the phase 3 DESTINY-Breast 04 trial.
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Oral ibrexafungerp for treating acute VVC
February 18th 2022Patients with acute vulvovaginal candidiasis (VVC) greatly benefited from oral ibrexafungerp (Brexafemme, Scynexis), according to results of a global phase 3 randomized, double-blind, placebo-controlled superiority study published in the international journal of obstetrics and gynecology, BJOG.
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Immunotherapy approvals shine light on need for molecular testing in endometrial cancer
February 1st 2022Sarah Lee, MD, MBA, discusses the use of checkpoint inhibitors in endometrial cancer, research regarding the association between MSI-H, dMMR, and TMB-H disease, and the importance of broad molecular testing to ensure all eligible patients are appropriately matched to immunotherapeutic options.
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Relugolix for treating uterine fibroids
January 19th 2022A phase 2, multicenter study has found relugolix (Myfembree; Myovant Sciences) significantly decreases menstrual blood loss in women with uterine leiomyomas and is mostly well tolerated. Relugolix is a small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist.
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Mirvie RNA test aims to predict pregnancy complications
January 13th 2022Maneesh Jain, CEO and co-founder of Mirvie, a proprietary RNA platform that uses blood samples to predict pregnancy complications such as preeclampsia, sits down with Contemporary OB/GYN to discuss the potential of the test.
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