1/9/2019
Nexvax2 Therapeutic Vaccine Fast-Tracked by FDA
ImmusanT, Inc., has announced that its therapeutic vaccine candidate, Nexvax2, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).
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Tag: fda
2/15/2018
The Celiac Disease Foundation Submits Comment to FDA on Draft Guidance Regarding Gluten in Medications
On December 12, 2017, the Food & Drug Administration (FDA) issued guidance to drug manufacturers to voluntarily label medications that do not contain gluten with the following statement: “Contains no…
Continue Reading1/10/2018
Marilyn’s Message January 2018
“Fail faster” is a saying in drug research. In 2014, the Tufts Center for the Study of Drug Development estimated that the average cost of bringing a new drug through…
Continue Reading12/13/2017
FDA Issues Gluten in Drug Products and Associated Labeling Recommendations
The Food & Drug Administration (FDA), on December 12, 2017, issued guidance to drug manufacturers to voluntarily label medications with a statement indicating that gluten-containing ingredients were not used to…
Continue Reading9/19/2017
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…
Continue Reading6/7/2017
New Sampling Data on Compliance with FDA Gluten-Free Labeling Rule
On August 2, 2013, the Food and Drug Administration issued a final rule defining “gluten-free” for food labeling to help consumers, especially those living with celiac disease and non-celiac gluten/wheat sensitivity,…
Continue Reading4/7/2017
FDA Allows Marketing of First Direct-to-Consumer Tests That Provide Genetic Risk Information for Certain Conditions, Including Celiac Disease
23andMe has been approved by the FDA to offer direct-to-consumer genetic screening for a number of diseases, including celiac disease. Consumers are strongly cautioned to consult their physician
Continue Reading4/7/2017
FDA Allows Marketing of First Direct-to-Consumer Tests That Provide Genetic Risk Information for Certain Conditions, Including Celiac Disease
Celiac Disease Foundation welcomes the FDA announcement that 23andMe can offer accessible, lower-cost, direct-to-consumer genetic screening for a number of diseases, including celiac disease. Celiac disease is a serious, genetic,…
Continue Reading2/28/2017
Partnership with ImmusanT to Promote Phase 2 Clinical Trial of Nexvax2®, A Promising Celiac Disease Treatment
ImmusanT, a Cambridge, MA-based biotechnology company, has announced that Nexvax2®, an immunotherapy drug designed to protect celiac disease patients from gluten exposure, has successfully completed a Phase 1b clinical trial…
Continue Reading7/22/2015
A GREAT Day for Celiac Disease
Celiac Disease Foundation is proud to have been a funder and to participate on the Steering Committee for the FDA Gastroenterology Regulatory Endpoints and Advancement of Therapeutics (GREAT3) workshop. Conceived…
Continue ReadingRecent Posts
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- The 2024 Nobel Prize in Chemistry goes to a leading celiac disease researcher
- Cooking Up Health: New Paper Details How Culinary Medicine Can Empower Patients Living with Chronic Diseases
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Marilyn's Message
9/26/2024
Read more2024 International Celiac Disease Symposium Recap
Last month, the Celiac Disease Foundation had the privilege of sponsoring the 2024 International Celiac Disease Symposium in Sheffield, UK. As the first patient advocate invited to chair and present on a scientific panel, CEO Marilyn Geller co-chaired the End Points in Clinical Trials session with Dr. Francisco Leon, CEO...