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Tagged With "DBV"

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DBV Submits Viaskin Peanut Treatment for FDA Biologics License

KFA News Team ·
DBV Technologies today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Viaskin Peanut for the treatment of peanut allergy in children four to 11 years of age. Viaskin Peanut is the Company’s lead product candidate, which is based on epicutaneous immunotherapy (EPIT), a proprietary technology platform that delivers biologically active compounds to the immune system
Blog Post

FDA Accepts Application for Viaskin Peanut Patch for Review

KFA News Team ·
DBV Technologies, a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for its investigational Viaskin® Peanut immunotherapy for the treatment of peanut-allergic children ages 4 to 11 years. Viaskin Peanut is the Company’s lead product candidate designed to potentially reduce the risk of life-threatening allergic reactions due to accidental exposure to peanuts.
Blog Post

FDA Application for Peanut Patch for Children 4 to 11 Years of Age Is Withdrawn

KFA News Team ·
DBV Technologies today announced that after discussions with the U.S. Food and Drug Administration (FDA), its Biologics License Application (BLA) for Viaskin Peanut in children four to 11 years of age has been voluntarily withdrawn. DBV is currently working closely with the agency to resubmit the application for Viaskin Peanut as quickly as possible.
Blog Post

DBV Announces Phase III Trial Results for Viaskin Peanut

KFA News Team ·
DBV Technologies Announces Publication of Detailed Phase III Trial Results Evaluating Viaskin Peanut as a Novel Treatment for Peanut Allergy in The Journal of the American Medical Association
Blog Post

DBV Resubmits Viaskin Peanut Allergy Treatment to FDA

KFA News Team ·
DBV Technologies, a clinical-stage biopharmaceutical company, today announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Viaskin® Peanut for the treatment of peanut-allergic children ages 4 to 11 years.
Kids With Food Allergies
A Division of the Asthma and Allergy Foundation of America
1235 South Clark Street Suite 305, Arlington, VA 22202
Phone: 1-800-7-ASTHMA (1.800.727.8462)
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