Signs Of Life In The Bacterial Vaginosis, Vulvovaginal Candidiasis Pipeline
Scynexis highlights enrollment exceeding expectations in Phase III VVC trials; Daré prepares to enter Phase III to treat BV.
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Keeping Track: Spectrum Submits Poziotinib; US FDA Approves Daré’s Xaciato, Expands Heron Zynrelef Label
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Filing Imminent As Mycovia’s Antifungal Prevents Recurrent Vulvovaginal Candidiasis
Oteseconazole prevented recurrent VVC in two Phase III studies but Phase III data in acute treatment of VVC episodes in women with RVVC, also due this month, are needed to file for US FDA approval in the first half of 2021.
Scynexis Prepares For NDA Filing With Second Phase III Success In VVC
Novel antifungal ibrexafungerp, a first-in-class triterpenoid, demonstrates ability to clear vulvovaginal candidiasis infections in second pivotal study; firm also looks to demonstrate efficacy in recurrent infections.