eDrugstore – 716505 – 09/09/2025

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTERSeptember 9, 2025eDrugstore:This letter is to advise you that the United States...

CBER 2026 Orphan Approvals (new BLAs)

This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed by date of approval in reverse chronological order.Trade Name/Proper...