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Viaskin Peanut

FDA Issues Partial Hold on DBV Viaskin Peanut Patch Trial

Another delay for the long-awaited therapy.
Viaskin Patch

DBV Begins Phase 3 Study of Redesigned Viaskin Peanut Patch in Children Ages 4-7

Viaskin is testing a new version of their patch designed to address the FDA's concerns.
Viaskin Patch

DBV Announces Positive Topline Results from Phase 3 Trial of Viaskin Peanut in Peanut-Allergic...

Viaskin Peanut demonstrated a statistically significant treatment effect with 67.0% of subjects meeting the treatment responder criteria after 12 months.
Viaskin Patch

Viaskin Peanut Patch Therapy Delayed Further as DBV Readies Another Phase 3 Trial

The patch therapy remains in regulatory limbo.
Viaskin-Patch

Safety of Viaskin Peanut Patch Therapy Improved Over 3-Year Study

Reactions decreased over study duration.
Viaskin Peanut

FDA Wants More Viaskin Peanut Data Resulting in Further Approval Delays

Delays mount pushing trials of modified patch.
Viaskin Patch

DBV Optimistic Viaskin Peanut “Patch” Therapy has Path to Approval After FDA Feedback

DBV, which also has Viaskin therapies for milk and egg allergies in their pipeline, is encouraged by FDA feedback after denial of their peanut therapy.
Viaskin Patch

Viaskin Peanut “Patch” Therapy Takes Next Step Toward Approval… in Europe

The Marketing Authorization Application for Viaskin™ Peanut was validated by the European Medicines Agency.
Viaskin Peanut

FDA Denies Approval of Viaskin Peanut “Patch” Therapy

The FDA raised concerns that adhesion of the patch would affect the efficacy of the therapy.
Viaskin-Patch-Delay

FDA Has Questions About Viaskin Peanut Efficacy, Delays Meeting with DBV Technologies

The company warned the FDA's target date for their decision on approval could be delayed.