Bridget Silverman
Senior Editor
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Latest From Bridget Silverman
Priority Review Vouchers Post Lower Average Approval Times Than Priority NMEs
US FDA’s priority review voucher program delivers for most sponsors, a Pink Sheet analysis finds; PRVs reliably produce faster approval than priority-reviewed new drugs overall.
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.
US FDA Fulfills Annual Antibiotic Guidance Goal With Three Women’s Health Guidances
Final guidance documents for bacterial vaginosis, vulvovaginal candidiasis, and uncomplicated urinary tract infections contain few changes from draft.
One Patient, Many Questions: Milasen ‘N of 1’ Trial Provides Early Template For Individualized Genomic Medicine
Rapid development of patient-customized oligonucleotide at Boston Children’s Hospital suggests promise and hazards of new drug development model.
BeyondSpring’s Pivotal NSCLC Trial For Plinabulin Designed To Avoid Bavencio’s JAVELIN 200 Failure
Lessons learned about blinding and stratification from Pfizer and Merck KGaA’s earlier Phase III disappointment shaped the design of BeyondSpring's ongoing Phase III trial of plinabulin in second- and third-line non-small cell lung cancer.
Keeping Track: US FDA, Industry Roar Into Fourth Quarter With Bevy Of Regulatory Announcements
The latest drug development news and highlights from our US FDA Performance Tracker.