FDA Establishes Regulatory Review Period for Aucatzyl
February 13, 2026
February 13, 2026
WASHINGTON, Feb. 13 (TNSFR) -- The Food and Drug Administration (FDA) announced on Feb. 13, 2026, the formal determination of the regulatory review period for the human biological product Aucatzyl. This required notice follows applications for patent term restoration submitted by Autolus Ltd., London, England, to the U.S. Department of Commerce Patent and Trademark Office.
Aucatzyl, a chimeric antigen receptor (CAR) T-cell therapy, is approved for the treatment of adults with relaps . . .
Aucatzyl, a chimeric antigen receptor (CAR) T-cell therapy, is approved for the treatment of adults with relaps . . .