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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

Keeping Track: A Burst Of Breakthroughs, A Priority Review For Keytruda, And Some Supplemental Submissions

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

Spring Awakening: NDA Submissions To Watch For

If companies meet their publicly stated NDA filing targets, at least four breakthrough-designated therapies will arrive at US FDA in March. 

Keeping Track: FDA Approves Novel HIV Treatment, New Dosing Regimen For Opdivo; Another Rare Pediatric Disease Designation For Prometic

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

Drug Review Regulation

TaiMed's Trogarzo Is US FDA's First HIV/AIDS Breakthrough Approval

Unusual review of ibalizumab-uiyk marks other HIV firsts too: first monoclonal antibody and first new mechanism of action in 10 years. Company considered several routes of administration, and the Phase III trial was actually smaller than the Phase II study.
Drug Review Profile Drug Review

Companion Diagnostics In Oncologic Development: Idhifa And Lynparza Show Benefit Of Early Focus

Pink Sheet's Drug Review Profile looks at how Celgene's Idhifa sped from IND to approval, helped by prospective integration of a companion IDH2 mutation diagnostic into the clinical trial, while AstraZeneca's Lynparza was delayed by FDA concerns over retrospective analysis using germline BRCA mutation diagnostic.

Idhifa Clinical Development Timeline

Chronicle of development and US FDA review of Celgene and Agios' enasidenib for relapsed or refractory acute myelogenous leukemia harboring an IDH2 mutation.

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