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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. 
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Latest From Bridget Silverman

Baby Steps To Real-World Evidence Of Efficacy: External Controls Gain Popularity In Rare Disease Trials

The Pink Sheet takes a closer look at recent clinical announcements showing how rare disease therapy sponsors are already increasingly reliant on natural history studies to guide drug development.

Drug Approval Standards Rare Diseases

Keeping Track: NME Approvals For Evenity And Balversa; Non-NME Approvals For Dovato And Keytruda; But An RTF For Fintepla

The latest drug development news and highlights from our US FDA Performance Tracker. 
US FDA Performance Tracker Drug Review

Keeping Track: Approvals For Mayzent, Mavenclad, Duaklir, Jatenzo And Cimzia

The latest drug development news and highlights from our US FDA Performance Tracker.

Drug Review Regulation

Keeping Track: Two Goal Date Extensions, Another Herceptin Biosimilar Approval, And A BLA Withdrawal

The latest drug development news and highlights from our US FDA Performance Tracker.
Drug Review Regulation

Real-Time Oncology Review Quickly Grows Popular; Venclexta Is Latest To Join Pilot

Genentech/AbbVie drug becomes the seventh product known to be pilot-testing US FDA's new pathway; our infographic details the program's goals and how it has been used so far for more efficient reviews of supplemental oncology indications.
Drug Review Review Pathway

Breakthrough Designation Rescissions: Who Might US FDA Drop Next?

Our chart details the pipeline candidates who might lose the coveted status as treatment paradigms change and trial results come in.
Review Pathway Drug Review
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