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DBV Technologies (DBVT) FDA Events

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FDA Events for DBV Technologies (DBVT)

This section highlights FDA-related milestones and regulatory updates for drugs developed by DBV Technologies (DBVT). Over the past two years, DBV Technologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Viaskin. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Viaskin Peanut (EPITOPE) - FDA Regulatory Timeline and Events

Viaskin Peanut (EPITOPE) is a drug developed by DBV Technologies for the following indication: Peanut-allergic toddlers ages 1 to 3 years. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

DBV Technologies FDA Events - Frequently Asked Questions

As of now, DBV Technologies (DBVT) has not received any FDA approvals for its therapy in the last two years.

In the past two years, DBV Technologies (DBVT) has reported FDA regulatory activity for Viaskin Peanut (EPITOPE).

The most recent FDA-related event for DBV Technologies occurred on March 24, 2025, involving Viaskin Peanut (EPITOPE). The update was categorized as "FDA Meeting Request," with the company reporting: "DBV Technologies announced that in a Written Responses Only to the Company's Type D IND meeting request, the U.S. Food and Drug Administration (FDA) agreed with the Company's proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 – 7-year-olds will be sufficient to support a Biologics License Application (BLA) filing in this age group."

Currently, DBV Technologies has one therapy (Viaskin Peanut (EPITOPE)) targeting the following condition: Peanut-allergic toddlers ages 1 to 3 years.

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:DBVT) was last updated on 7/10/2025 by MarketBeat.com Staff
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