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Drug Pipeline News

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.

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.

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.