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DBV to Resubmit Application to FDA for Viaskin Peanut Approval in Q3 2019
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 No Safety Concerns
Part B expected to commence in 2018Q4 with Viaskin Peanut 250 µg.
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 Approval
The Viaskin Peanut patch therapy still has 50:50 chance of approval according to research note.
Viaskin Peanut Patch: Lasting Response After Three Years
Pediatric patients responded with a favorable safety profile and no serious adverse effects.
Viaskin Peanut, Milk and Egg Patch Therapies: Promising News from the AAAAI Conference
We are cautiously optimistic that a safe, effective, easy to administer treatment for food allergy may be on the horizon.
Viaskin Patch Delivers Long-Lasting Peanut Desensitization After Phase IIb Trial
The study was designed to assess the long-term efficacy and safety of the treatment in subjects that had graduated from their earlier VIPES trial.
Non-Profit Institute to Review Benefits of Commercial, Private Practice Immunotherapies for Peanut Allergy
An independent review of the value, costs and effectiveness of Viaskin Peanut, AR101, and private practice peanut OIT.
