Sue Sutter

Sue is a senior editor with Pink Sheet, where she writes primarily about drug, biologic and biosimilar regulation, FDA advisory committees and product approvals.

Recent posts

Biogen’s AdComm Meeting Will Test FDA’s “Substantial Evidence” Flexibility
A US Food and Drug Administration advisory committee meeting on Biogen, Inc.’s Alzheimer’s drug aducanumab will offer some insight into the amount of flexibility the agency and its external experts are... Read more »
Gene Therapy Firms Seek Clarity on FDA Exclusivity, Orphan Designations
Gene therapy product developers are seeking more clarity from the US Food and Drug Administration on when viral vectors from the same class will be considered sufficiently different for purposes of... Read more »

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Sue Sutter

Recent posts

Biogen’s AdComm Meeting Will Test FDA’s “Substantial Evidence” Flexibility

Gene Therapy Firms Seek Clarity on FDA Exclusivity, Orphan Designations

Underwriters and Partners

Navigating Challenges & Advancing Clinical Development: A Toolkit for Emerging Biotechs

Nov. 12 – High-Throughput Assessment of Compound-Induced Cardiotoxicity Using Human iPSC-Derived Cardiomyocytes

The Importance of Early Planning for Biotechs & Engaging with a CRO for Molecule Development

Xconomy on Demand

We offer a number of ways to subscribe for free!