Tag: DBV Technologies
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.
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.
DBV to Resubmit Application to FDA for Viaskin Peanut Approval in...
Company allays concerns that BLA would not be resubmitted.
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.
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 Peanut Completes Phase III Part A Study of Toddlers With...
Part B expected to commence in 2018Q4 with Viaskin Peanut 250 µg.
