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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: Poteligeo, Onpattro, Galafold And Annovera Approved; Selinexor Submitted

The latest drug development news and highlights from our US FDA Performance Tracker.
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Blincyto Timeline And Reviewers

Overview of development timeline and review team for Amgen’s Blincyto (blinatumomab) for relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL).

A Baker’s Dozen Of US FDA Efficacy Approvals Using Real World Evidence

Fresenius Kabi’s Omegaven is most recent of 13 approvals, including three with breakthrough therapy designations, where FDA has relied on real world evidence to make a regulatory decision about efficacy.
Drug Approval Standards Drug Review

Bavencio Review Timeline And Reviewers

Overview of development timeline and review team for EMD Serono’s Bavencio (avelumab) for metastatic Merkel cell carcinoma.
Drug Review Profile Drug Review

Real-World Evidence At US FDA: Bavencio, Blincyto Approvals Point Way Toward Broader Use

Breakthrough-designated oncologics used historical comparator data to determine efficacy threshold for pivotal Phase II studies supporting accelerated approval; Blincyto’s subsequent full approval offers validation with conventional controlled study. 
Drug Review Profile Drug Approval Standards

Keeping Track: Shionogi, Fresenius Kabi Join July Approval Parade; Busy August Expected

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

Drug Review Regulation
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