DBV Technologies Provides Update on Regulatory Progress for Viaskin Peanut

World News: . []

                                                                                                                                                                               DBV Technologies Provides Update on Regulatory Progress for Viaskin Peanut

DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT) today announced that the U.S. Food and Drug Administration (FDA) has agreed that the available efficacy and safety data for Viaskin Peanut supports the submission of a Biologics License Application (BLA) for the treatment of peanut allergy in children four to 11 years of age.

The FDA provided written responses to the clinical pre-BLA meeting package submitted by the Company, which reflect agreement on the content of the clinical module of the BLA for Viaskin Peanut. DBV remains on track to submit its BLA in the second half of 2018.


More news and information about DBV Technologies S.A.

Published By:

Globe Newswire: 06:31 GMT Wednesday 14th February 2018

Published: .

Search for other references to "technologies" on SPi News

Previous StoryNext Story

SPi News is published by Sector Publishing Intelligence Ltd.
© Sector Publishing Intelligence Ltd 2018. [Admin Only]
Sector Publishing Intelligence Ltd.
Ground Floor Offices, Little Keep Gate, Barrack Road, Dorchester, Dorset DT1 1AH
Registered in England and Wales number 0751938.
Privacy Policy | Terms and Conditions | Contact Us

Advertising on SPi News: Information For Advertisers