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Printed By

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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Keeping Track: US FDA Clears Three Novel Agents Over Three Days – Bavencio, Symproic And Xadago

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

Performance Tracker Approvals

A Pathway, Not A Shortcut: 505(b)(2) NDAs Have Longer Reviews Than NMEs

US FDA's argument that its review resources favor novelty/medical advances could be buttressed by Tufts Center for the Study of Drug Development analysis of (less novel) approvals using the streamlined 505(b)(2) NDA pathway.

Drug Review Drug Approval Standards

Keeping Track: US FDA Clears Kisqali For Breast Cancer And Keytruda In Lymphoma, But Turns Down AZ's ZS-9 Again

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

Approvals Complete Response Letters

Keeping Track: US FDA Accepts Ertugliflozin, Extends Reviews Of Abaloparatide, New Keytruda Claim

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

Approvals Review Pathway

A Tale Of Two Desmopressins: Trial Design Gave Noctiva Advantage Over Nocdurna, US FDA Says

Serenity's Noctiva and Ferring's Nocdurna both use desmopressin to treat nocturia, but Nocdurna has racked up three complete response letters while Noctiva was approved on the first try. US FDA explains how trial design and secondary endpoints influenced its decision in its denial of a Ferring citizen petition.

Drug Review Approvals

Keeping Track: Xermelo, Odactra, Noctiva Approved; Second Submissions For Avelumab And Deutetrabenazine

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

Approvals Regulation
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