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Viaskin Patch

DBV Optimistic Viaskin Peanut “Patch” Therapy has Path to Approval After FDA Feedback

DBV, which also has Viaskin therapies for milk and egg allergies in their pipeline, is encouraged by FDA feedback after denial of their peanut therapy.
Viaskin Patch

Viaskin Peanut “Patch” Therapy Takes Next Step Toward Approval… in Europe

The Marketing Authorization Application for Viaskin™ Peanut was validated by the European Medicines Agency.
Viaskin Peanut

FDA Denies Approval of Viaskin Peanut “Patch” Therapy

The FDA raised concerns that adhesion of the patch would affect the efficacy of the therapy.
Viaskin-Patch-Delay

FDA Has Questions About Viaskin Peanut Efficacy, Delays Meeting with DBV Technologies

The company warned the FDA's target date for their decision on approval could be delayed.
Viaskin-Patch

FDA Advisory Committee Meeting to Review Viaskin Peanut for the Treatment of Peanut Allergy...

Next step in the approval process for the therapy scheduled for May 15, 2020.
Viaskin Peanut

DBV Technologies Reports Positive Three-Year, Long Term Data from Phase III Open-Label Extension Study...

Patients demonstrated durable, long-term clinical benefit with an additional two years of treatment.
Viaskin Peanut

DBV Technologies Announces FDA Acceptance of BLA filing for Viaskin Peanut for the Treatment...

If approved, Viaskin Peanut would be the first and only epicutaneous immunotherapy indicated for this potentially life-threatening condition in children.
Viaskin Patch

DBV Technologies Submits Biologics License Application to FDA for Viaskin Peanut for the Treatment...

This submission addresses the additional data needed on manufacturing procedures and quality controls which were communicated by the FDA in December.
Viaskin Peanut

DBV to Resubmit Application to FDA for Viaskin Peanut Approval in Q3 2019

Company allays concerns that BLA would not be resubmitted.
Viaskin Peanut

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.