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In this section: Vaccines, Blood & Biologics

CBER 2025 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 Name	Indication	Manufacturer/License Number	Approval Date
ENCELTO	for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel)	Neurotech Pharmaceuticals	3/5/2025

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