Tag: Viaskin® Peanut

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, About to Become the First FDA Approved Therapy...

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).
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.
OIT

Leading Allergists, Researchers and Food Allergy Advocates to Discuss State of...

The summit intends to address the risks and benefits of OIT, OIT implementation in practice and the gaps in knowledge about OIT to enable physicians to have a better understanding of this therapy and to help patients make fully-informed choices about treatment options.
Viaskin Peanut

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

Company allays concerns that BLA would not be resubmitted.

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