Tag: Viaskin® Peanut

Viaskin Patch

Will the Viaskin “Patch” Therapy for Peanut Allergy be Approved Soon?...

Company is restructuring in anticipation of delays.
Viaskin-Patch-Delay

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.
Viaskin-Patch

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.
Viaskin Peanut

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.
Viaskin Peanut

DBV Technologies Announces FDA Acceptance of BLA filing for Viaskin Peanut...

If approved, Viaskin Peanut would be the first and only epicutaneous immunotherapy indicated for this potentially life-threatening condition in children.
Paliforzia (AR101)

FAQ for Palforzia, the First FDA Approved Therapy for Food Allergy

What it is, what it treats, who it is for, how it is used, et al.
Viaskin Patch

DBV Technologies Submits Biologics License Application to FDA for Viaskin Peanut...

This submission addresses the additional data needed on manufacturing procedures and quality controls which were communicated by the FDA in December.
FARE Reponse to ICER Report

Fare Responds to Final ICER Review of Breakthrough Peanut Allergy Therapies

FARE expresses its deep concerns with the final evidence report on two breakthrough peanut allergy therapies issued Wednesday by ICER.
AAFA Reponse to ICER Report

Asthma and Allergy Foundation of America Responds to Premature ICER Review...

The AAFA addresses concerns regarding the Final Evidence Report released by the ICER.
ICER Final Report

ICER’s Final Report on Peanut Allergy Treatments: Clinical Evidence Does Not...

The report evaluates Viaskin® Peanut and AR101, as well as non-commercialized oral immunotherapy (OIT).