Tag: DBV Technologies
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.
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.
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.
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 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.
Asthma and Allergy Foundation of America Responds to Premature ICER Review...
The AAFA addresses concerns
regarding the Final Evidence Report released by the ICER.
