Tag: Biologics License Application (BLA)
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.
US FDA Accepts BLA Filing of Aimmune Therapeutics’ AR101 for Peanut...
If Approved, AR101 Will Be the First Medicine for This Life-Threatening Condition.
DBV to Resubmit Application to FDA for Viaskin Peanut Approval in...
Company allays concerns that BLA would not be resubmitted.
Government Shutdown Delays Review of AR101 Peanut Oral Immunotherapy Candidate
The FDA has shelved consideration of the drug until funding is restored.
Aimmune Submits FDA Application to Offer AR101 for the Treatment of...
“We have requested FDA Priority Review and look forward to working with the agency to bring what could be the first approved treatment in food allergy to patients as quickly as possible.”
