Tag: Daniel Tassé
FDA Removes Hold Allowing DBV’s Pivotal Phase 3 Peanut Patch Trial...
The phase 3 trial of the modified Viaskin Peanut patch has been cleared for commencement.
FDA Issues Partial Hold on DBV Viaskin Peanut Patch Trial
Another delay for the long-awaited therapy.
DBV Begins Phase 3 Study of Redesigned Viaskin Peanut Patch in...
Viaskin is testing a new version of their patch designed to address the FDA's concerns.
DBV Announces Positive Topline Results from Phase 3 Trial of Viaskin...
Viaskin Peanut demonstrated a statistically significant treatment effect with 67.0% of subjects meeting the treatment responder criteria after 12 months.
Viaskin Peanut Patch Therapy Delayed Further as DBV Readies Another Phase...
The patch therapy remains in regulatory limbo.
FDA Wants More Viaskin Peanut Data Resulting in Further Approval Delays
Delays mount pushing trials of modified patch.
DBV, Developers of Patch Therapies for Allergies to Peanuts, Milk and...
The company announced they would be laying off 200 employees in Q1.
FDA Denies Approval of Viaskin Peanut “Patch” Therapy
The FDA raised concerns that adhesion of the patch would affect the efficacy of the therapy.
Will the Viaskin “Patch” Therapy for Peanut Allergy be Approved Soon?...
Company is restructuring in anticipation of delays.
FDA Has Questions About Viaskin Peanut Efficacy, Delays Meeting with DBV...
The company warned the FDA's target date for their decision on approval could be delayed.
