Tag: DBV Technologies
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.
Milk and Peanut Clinical Trial Advances
Announcements regarding two food allergy therapies that are in or advancing toward clinical trials were made yesterday.
Positive Safety Results Reported for Viaskin Peanut Phase III Trial
The trial met its primary objective, demonstrating that Viaskin Peanut was well-tolerated with no new or unexpected adverse events.
Viaskin Peanut Phase III Trial Falls Short, Still Chance for FDA...
The Viaskin Peanut patch therapy still has 50:50 chance of approval according to research note.
DBV Completes Phase III Study of Peanut Patch
The phase III trial was designed to assess the safety and routine clinical use of Viaskin Peanut.
Study: Peanut Immunotherapy Significantly Reduces Risks Due to Cross-Contact in Common...
The study model used common packaged foods such as cookies, ice cream, and doughnuts as references.
Viaskin Peanut Patch: Lasting Response After Three Years
Pediatric patients responded with a favorable safety profile and no serious adverse effects.
