Search for "viaskin peanut"

DBV Outlines Path to Regulatory Approval of Viaskin Peanut Patch

Dave Bloom - 2023/04/21 0

Are Viaskin therapies finally on the horizon?

FDA Issues Partial Hold on DBV Viaskin Peanut Patch Trial

Dave Bloom - 2022/09/22 0

Another delay for the long-awaited therapy.

DBV Begins Phase 3 Study of Redesigned Viaskin Peanut Patch in Children Ages 4-7

Dave Bloom - 2022/09/14 0

Viaskin is testing a new version of their patch designed to address the FDA's concerns.

DBV Announces Positive Topline Results from Phase 3 Trial of Viaskin Peanut in Peanut-Allergic...

News Wire ~ 3rd Party Press Release - 2022/06/08 0

Viaskin Peanut demonstrated a statistically significant treatment effect with 67.0% of subjects meeting the treatment responder criteria after 12 months.

Viaskin Peanut Patch Therapy Delayed Further as DBV Readies Another Phase 3 Trial

Dave Bloom - 2021/12/22 0

The patch therapy remains in regulatory limbo.

Safety of Viaskin Peanut Patch Therapy Improved Over 3-Year Study

Dave Bloom - 2021/11/11 0

Reactions decreased over study duration.

FDA Wants More Viaskin Peanut Data Resulting in Further Approval Delays

Dave Bloom - 2021/10/27 0

Delays mount pushing trials of modified patch.

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

Dave Bloom - 2021/01/21 0

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

Dave Bloom - 2020/11/03 0

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

FDA Denies Approval of Viaskin Peanut “Patch” Therapy

Dave Bloom - 2020/08/04 0

The FDA raised concerns that adhesion of the patch would affect the efficacy of the therapy.

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