Tag: Epicutaneous Immunotherapy (EPIT)
Will the Viaskin “Patch” Therapy for Peanut Allergy be Approved Soon?...
Company is restructuring in anticipation of delays.
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.
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.
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.
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).
Asthma and Allergy Foundation of America Elevates Patient Voice in ICER...
Affirms Burden of Food Allergies on Families, Patients, and Caregivers.
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.
Must See: 'ViewFinder: Food for Thought – Food Allergies'
This documentary should be required viewing for everyone as the food allergy epidemic has affected so many in the community.
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.
