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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 Children Ages 4-7
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 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 Peanut Patch Therapy Delayed Further as DBV Readies Another Phase 3 Trial
The patch therapy remains in regulatory limbo.
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.
DBV, Developers of Patch Therapies for Allergies to Peanuts, Milk and Eggs, to Lay...
The company announced they would be laying off 200 employees in Q1.
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.
DBV Technologies Reports Positive Three-Year, Long Term Data from Phase III Open-Label Extension Study...
Patients demonstrated durable, long-term clinical benefit with an additional two years of treatment.
DBV Technologies Announces FDA Acceptance of BLA filing for Viaskin Peanut for the Treatment...
If approved, Viaskin Peanut would be the first and only epicutaneous immunotherapy indicated for this potentially life-threatening condition in children.
DBV Technologies Submits Biologics License Application to FDA for Viaskin Peanut for the Treatment...
This submission addresses the additional data needed on manufacturing procedures and quality controls which were communicated by the FDA in December.
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