FDA Determines Regulatory Review Period for ADBRY in Patent Extension Case
May 14, 2025
May 14, 2025
WASHINGTON, May 14 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has published a determination regarding the regulatory review period for ADBRY (tralokinumab), a human biologic product used in the treatment of moderate-to-severe atopic dermatitis. The FDA's determination, which follows a request from the U.S. Patent and Trademark Office (USPTO), is essential for a patent term restoration application submitted by MedImmune Ltd., the manufactur . . .