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ImmusanT Finds Celiac Disease Might Be Diagnosed With A Single Gluten Challenge

ImmusanT, a clinical-stage company developing Nexvax2®, a therapeutic vaccine intended to protect against the effects of gluten exposure while maintaining a gluten-free diet, presented data at the 2017 International Celiac Disease Symposium (ICDS) in Delhi, India for a potential blood test that could detect celiac disease with a single gluten challenge. This blood test could also […]

How Will New FDA Strategies to Evaluate Benefits vs. Risks Impact Drug Development and Approval for Celiac Disease, Non-Celiac Gluten/Wheat Sensitivity, and Their Comorbidities?

On September 18, 2017, Celiac Disease Foundation (CDF) representatives attended a Food and Drug Administration (FDA) meeting in White Oak, MD on the ongoing implementation of a benefit-risk framework to inform drug and medical device review and approval processes. Under legislative mandate, the FDA is seeking to formally incorporate the patient experience and perspective into […]

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