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Sue Sutter

Senior Editor

Washington, D.C.
Sue is a senior editor with Pink Sheet, where she writes primarily about drug, biologic and biosimilar regulation, FDA advisory committees and product approvals.  She has reported on the prescription and over-the-counter drug industries since 1999 for various publications now under the umbrella of Informa Business Information, including Pink Sheet, “The Pink Sheet” DAILY, “The Tan Sheet” and Scrip.  Previously she worked as an editor for Mealey’s Litigation Reports (now part of Lexis-Nexis), writing about asbestos, toxic tort and fen-phen litigation.
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Latest From Sue Sutter

Keytruda, Tecentriq Face Efficacy Questions In Urothelial Cancer

Monotherapy patients with tumors that have low PD-L1 expression experienced decrease survival in two confirmatory trials; however, the immune checkpoint inhibitors’ accelerated approvals are unlikely to be affected pending final results comparing use in combination with chemotherapy to chemo alone.


ImmunoOncology Clinical Trials

Keeping Track: A Diverse Array Of Approvals, A CRL For Evolus' Botox Competitor, And Coherus Refiles Neulasta Biosimilar

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

Lutathera Clinical Development Timeline

Chronicle of the development and US FDA review of Advanced Accelerator Applications' lutetium Lu 177 dotatate for gastroenteropancreatic neuroendocrine tumors.


Drug Review Profile Drug Review

Lutathera Reviewers

US FDA staff who participated in the review and approval of AAA's treatment for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.


Drug Review Profile Drug Review

Giapreza Reviewers

US FDA staff who participated in the review and approval of La Jolla Pharmaceutical's distributive shock treatment.


Drug Review Profile Drug Review

Lutathera’s Broad Tumor Indication Aided By Expanded Access Data

US FDA’s approval of Advanced Accelerator Applications’ radiopharmaceutical for gastroenteropancreatic neuroendocrine tumors was driven by robust Phase III study results in midgut carcinoid tumors and data from an investigator-initiated, expanded access study in the Netherlands that enrolled patients with a host of other neuroendocrine tumor types.

Drug Review Profile Drug Review
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