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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

Takeda/Shire Merger: Five Things To Worry About

From 'breakthrough' designations to manufacturing hiccups, numerous review and development challenges await the combined entity.

Drug Review Research & Development

User Fee Forecast For May: Approvals Could Sprout In Multiple Divisions

Aimovig, Andexxa, Lucemyra, and pegvaliase are among the almost 20 products with upcoming user fee goals at US FDA this month.

Drug Review Regulation

Immuno-Oncology At US FDA: Where Are The PD-1/L1 Inhibitor Applications?

Infographic guide to the almost 40 indications for burgeoning PD-1/L1 checkpoint inhibitor class either approved or under review, from the Pink Sheet's FDA Performance Tracker. 
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Keeping Track: Good News/Bad News For Pfizer; Filings For Brexanolone, Risankizumab

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

No Safety Shortcuts Under Breakthrough Designation, Synthetic Biologics Finds

Synthetic Biologics emerged from meetings with US FDA without its breakthrough designation, but with hope that agency will allow decoupling of safety and efficacy endpoints in planned Phase III trial for prevention of C. difficile infection.
Drug Approval Standards Drug Safety

Keeping Track: A Fresh Wave Of Approvals

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