Tag: Viaskin® Peanut
FDA Wants More Viaskin Peanut Data Resulting in Further Approval Delays
Delays mount pushing trials of modified patch.
New Microneedle Patch Therapy for Food Allergies Takes Step Forward
Painless microneedle patch may provide new method for desensitization.
DBV Optimistic Viaskin Peanut “Patch” Therapy has Path to Approval After...
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...
The company announced they would be laying off 200 employees in Q1.
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.
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.
FDA Advisory Committee Meeting to Review Viaskin Peanut for the Treatment...
Next step in the approval process for the therapy scheduled for May 15, 2020.
DBV Technologies Reports Positive Three-Year, Long Term Data from Phase III...
Patients demonstrated durable, long-term clinical benefit with an additional two years of treatment.
