Tag: Biologics License Application (BLA)

Viaskin Patch

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.
AR101

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.
AR101

US FDA Accepts BLA Filing of Aimmune Therapeutics’ AR101 for Peanut...

If Approved, AR101 Will Be the First Medicine for This Life-Threatening Condition.
Viaskin Peanut

DBV to Resubmit Application to FDA for Viaskin Peanut Approval in...

Company allays concerns that BLA would not be resubmitted.
AR101 Delayed by Gov't Shutdown

Government Shutdown Delays Review of AR101 Peanut Oral Immunotherapy Candidate

The FDA has shelved consideration of the drug until funding is restored.
AR101

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.”
Viaskin Peanut

DBV Withdraws FDA Application for Viaskin Peanut with Plan to Resubmit

The company believes the additional information needed to support this filing is available without further clinical studies.
Viaskin Peanut

DBV Applies for FDA License to Sell Viaskin Peanut Patch Therapy

"This submission represents a significant step forward for those families living with peanut allergy."
AR101

Peanut OIT Phase 3 Trial Results Show Therapy Effective for Ages...

Aimmune plans to submit a Biologics License Application for AR101 to the FDA by the end of 2018.
AR101

Aimmune to Submit FDA Application for Peanut OIT Candidate by End...

If approved, AR101 could be offered as the first FDA approved OIT therapy for peanut allergy.

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