New Drug Approvals

Track new FDA drug approvals, breakthrough designations, and generic releases.

🔮 Pipeline tracker (PDUFA dates, breakthrough designations) — deferred.

Showing FDA approvals from the past 12 months. First-in-class drugs marked with special designation.

Biologics License Application

Biologic product with new active ingredient

Recent Biologics License Application Approvals

No approvals found

No approvals of this type in the past 12 months.