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Drug Pipeline News
Phase 3 ibrexafungerp data shows promising results for acute VVC treatment
July 21, 2022
The CANDLE open-label sub-study enrolled 24 patients with RVVC who failed to respond to fluconazole treatment, which was given as an initial 3-dose treatment over 7 days.
FDA turns down new drug application for oral UTI treatment
June 27, 2022
The 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.
Relugolix demonstrates positive phase 3 data as combination therapy for endometriosis pain
June 22, 2022
Results suggest the potential of this oral therapy to address the unmet clinical need for long-term medical treatment for endometriosis.
Evofem Biosciences announces results of post hoc analysis of phase 3 clinical trial data
June 21, 2022
Evofem 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.
Scynexis submits sNDA for expanded indication of ibrexafungerp tablets
June 08, 2022
Currently 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.
FDA accepts Myfembree sNDA for bleeding associated with uterine fibroids
June 02, 2022
The 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.
Recent studies investigate Phexxi for various potential indications
May 25, 2022
Bassem Maximos, MD, MPH, FACOG, discusses 2 recent studies investigating nonhormomal contraceptive gel Phexxi (Evofem Biosciences) for the potential treatment of UTIs and improvement in sexual satisfaction.
Materna Medical discusses new vaginal dilator
May 24, 2022
Tracy MacNeal, president and CEO of Materna Medical, sits down to discuss the company's recently FDA-cleared Milli Vaginal Dilator for vaginismus and associated dyspareunia, as well as a potential new use for the device currently being studied.
FDA approves first drug for RVVC
April 29, 2022
The US Food and Drug Administration has approved oteseconazole (Vivjoa; Mycovia Pharmaceuticals) to reduce the incidence of recurrent vulvovaginal candidiasis.
BD’s Onclarity HPV Assay: What it means for the future of cervical cancer detection
March 29, 2022
Pathology expert Mark H. Stoler, MD, discussed the BD Onclarity™ HPV Assay for primary HPV screening and what it means for the future of cervical cancer detection.