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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: 2021’s First Novel Approvals Go To HIV And Heart Failure Therapies Opdivo Starts Year With A Bang

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Even in the grip of the pandemic, review times for priority drugs were also consistent with the last three years.

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Breakthroughs, Orphans Hit High Notes As US FDA’s 2020 Novel Approvals Play A Familiar Tune

Influence of expedited review pathways and regulatory incentives is on display in 2020’s novel approvals, which have a composition reassuringly consistent with recent years.

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Keeping Track: Submissions Galore Start The New Year; US FDA Clears New Indications For Enhertu, Xalkori

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US FDA 2020 Novel Approval Count Rises To 53 At CDER, Plus 5 New CBER Biologics

FDA reviewers stuck to established assessment practices during the coronavirus crisis and produced one of the agency’s largest yearly novel approval counts ever.

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Spironolactone TOPCAT Regional Analysis Falls Short At US FDA AdComm, But Hospitalizations Drive Vote

A new indication for the generic diuretic in heart failure with preserved ejection fraction gets an 8-4 vote, with one abstention, despite troubles an analysis that tries to revive the TOPCAT trial with an analysis excluding Eastern European sites – or about half the participants.

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