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Product safetyFDAUnited StatesImports

Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure (MCM) Priority Review Voucher; Bixlenvo (Bictegravir and Lenacapavir)

28 October 2026

In plain English

FDA announces approval of Bixlenvo (bictegravir and lenacapavir) as a product redeeming a material threat MCM priority review voucher.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
28 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA) is announcing the approval of a product redeeming a material threat MCM priority review voucher. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the issuance of material threat MCM priority review vouchers as well as
The full text is at the source

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