Tag: Biologics License Application (BLA)
DBV Outlines Path to Regulatory Approval of Viaskin Peanut Patch
Are Viaskin therapies finally on the horizon?
Private Law Firm to Investigate Claims on Behalf of Investors in...
It is unknown how this development will affect the ability of the company to eventually offer Viaskin Peanut as an FDA approved therapy.
FDA Issues Partial Hold on DBV Viaskin Peanut Patch Trial
Another delay for the long-awaited therapy.
DBV Begins Phase 3 Study of Redesigned Viaskin Peanut Patch in...
Viaskin is testing a new version of their patch designed to address the FDA's concerns.
FDA Accepts Dupixent® (dupilumab) for Priority Review in Patients Aged 12...
If approved, Dupixent would be the first medicine available in the U.S. indicated to treat eosinophilic esophagitis.
Viaskin Peanut Patch Therapy Delayed Further as DBV Readies Another Phase...
The patch therapy remains in regulatory limbo.
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.
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.
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.
Aimmune Announces US FDA Advisory Committee Meeting Date for AR101 for...
The FDA will review Aimmune's Biologics Licence Application for AR101 on September 13, 2019.
