Vaginal Yeast Infections Are A Bright Spot For Anti-Infective Development
Working with US FDA was key to developing clinical trials in the absence of regulatory precedents in recurrent vulvovaginal candidiasis, Scynexis VP tells the Pink Sheet; exposure profiles drove different trial designs for Scynexis’ Brexafemme and Mycovia’s just-launched Vivjoa.
You may also be interested in...
Keeping Track: Rebyota, Rezlidhia Rev Up US FDA Approvals; New Sponsors Sought For Poziotinib, Brexafemme
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
November should see FDA action on what could be the first standardized fecal microbiota transplant product, rare cancer therapies from Y-mAbs and Spectrum, uniQure/CSL’s hemophilia B gene therapy and Provention Bio’s biologic to delay type 1 diabetes.
US FDA closed out the month of April with two new molecular entity approvals that address underserved markets but carry some safety concerns.