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Bridget Silverman

Senior Editor

Washington, D.C.
Bridget Silverman has been covering FDA for the Pink Sheet since David Kessler was commissioner.  She keeps watch on the drug review process for the FDA Performance Tracker and the Drug Review Profile series. She covered FDA and financial beats as a Pink Sheet reporter before focusing on the drug development and approval process as an editor on Pharmaceutical Approvals Monthly and the NDA Pipeline, developing products that inform our current regulatory tracking features and in-depth FDA review coverage. In her down time, Bridget reads mystery novels and keeps track of her family and three dogs. 

Latest From Bridget Silverman

Keeping Track: US FDA Clears Another CAR-T And Another Novel ADHD Drug; Submissions Blossom

The latest news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Approvals Drug Review

Keeping Track: Zegalogue Joins Hypoglycemia Space; Keytruda Earns First-Line Esophageal Cancer Claim

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Drug Review

April User Fee Goal Calendar: Forecast Uncertain For Atopic Dermatitis Candidates, Nuplazid; Eohilia Could Be First For Orphan Use

While some of the most prominent applications with user fee goal dates in April could be delayed, thanks to JAK inhibitor safety concerns and US FDA communications, the upcoming month should see more than 15 decisions on applications.

Complete Response Letters Approvals

Keeping Track: US FDA Approves J&J’s Novel MS Drug Ponvory, Breakthrough Pericarditis Claim For Kiniksa’s Arcalyst

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Regulation

Keeping Track: Recent NDA Submissions Range From Acute Agitation To Von Hippel-Lindau Disease

News and highlights of applications submitted for US FDA approval, from the Pink Sheet’s FDA Performance Tracker

US FDA Performance Tracker Drug Review

Pandemic Perspectives: US FDA ACTT’s On Its Faith In Randomized Trials With Veklury Approval Despite WHO Study

US FDA has not deviated from its bedrock trust in the value of ‘statistically reliable’ endpoints amidst the COVID-19 pandemic, the Pink Sheet’s Drug Review Profile of Gilead’s Veklury shows.

Drug Review Profile Coronavirus COVID-19
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