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FDA Establishes Regulatory Review Period for Amtagvi
February 13, 2026

WASHINGTON, Feb. 13 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration announced the determination of the regulatory review period for the human biological product Amtagvi. This notification is a required step following applications submitted by Iovance Biotherapeutics, San Carlos, California, to the U.S. Department of Commerce Patent and Trademark Office for patent term extensions.

Amtagvi is a biologic indicated for the treatment of adult pati . . .

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