Tag: Daniel Tassé

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

Will the Viaskin “Patch” Therapy for Peanut Allergy be Approved Soon?...

Company is restructuring in anticipation of delays.
Viaskin-Patch-Delay

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.
Viaskin-Patch

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.
Viaskin Peanut

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.
Viaskin Patch

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.
Viaskin Peanut

DBV to Resubmit Application to FDA for Viaskin Peanut Approval in...

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.