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Bridget Silverman
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Latest From Bridget Silverman
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.
Keeping Track: Intercept Submits OCA For NASH; Zogenix’ Fintepla Returns; US FDA Approves Bavarian Nordic Vaccine
The latest drug development news and highlights from our US FDA Performance Tracker