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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

Biogen Aducanumab BLA Plan Is In Line With US FDA Neurology Division Precedent

Biogen and Eisai's surprise decision to advance Alzheimer’s antibody despite mixed clinical results could follow a similar path as pioneering neurodegenerative therapies Xenazine and Rilutek, or more recent Parkinson’s drug Nourianz – or could end with suspended development, like Kyndrisa.
Neurology Drug Approval Standards

Chikungunya Vaccine Development May Rely On Immunologic Biomarkers Instead Of Traditional Trials

As the mosquito-borne chikungunya virus spreads into temperate regions worldwide, US FDA convenes advisory committee for an open discussion on development of vaccines.

Advisory Committees Vaccines

Hematology, Neurology Star In Swan Song For The Office Of New Drugs’ Division Structure

Pink Sheet analysis of three years of novel US FDA approvals show the swiftest average time to approval in oncology, hematology, and antiviral divisions; neurology and hematology divisions contributed the most approvals.

Drug Review Approvals

Keeping Track: Industry Beefs Up 2020 Review Pipeline With Submissions Galore

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

US FDA Performance Tracker Drug Review

Biogen Vumerity Receives Full US Approval, But GI Comparison With Tecfidera Must Wait

Label offers little differentiation from Tecfidera, but head-to-head trial with custom-designed patient-reported outcome could make case for gastrointestinal tolerability advantage.

Keeping Track: Vertex’ Trikafta Speeds To US Approval; New Indications For AZ’s Farxiga, J&J’s Stelara, GSK’s Zejula

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

US FDA Performance Tracker Drug Review
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