Tag: DBV Technologies

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).
AAFA Press Release Regarding ICER Review

Asthma and Allergy Foundation of America Elevates Patient Voice in ICER...

Affirms Burden of Food Allergies on Families, Patients, and Caregivers.
FARE-ACAAI-AAN Statement

Joint Statement on Peanut Allergy Therapy Review

Organizations representing patients and allergists urge ICER to adopt a more patient-driven approach to assessing immunotherapies for peanut allergy.
Viaskin Peanut

DBV to Resubmit Application to FDA for Viaskin Peanut Approval in...

Company allays concerns that BLA would not be resubmitted.
Viaskin Peanut

DBV Withdraws FDA Application for Viaskin Peanut with Plan to Resubmit

The company believes the additional information needed to support this filing is available without further clinical studies.
Viaskin Peanut

DBV Applies for FDA License to Sell Viaskin Peanut Patch Therapy

"This submission represents a significant step forward for those families living with peanut allergy."
Viaskin Patch

Viaskin Peanut Completes Phase III Part A Study of Toddlers With...

Part B expected to commence in 2018Q4 with Viaskin Peanut 250 µg.

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