FDA Announces Regulatory Review Period for EPKINLY Patent Extension
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 determined the regulatory review period for the biologic product EPKINLY, a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
This determination is part of the ongoing process to assess patent term restoration, following the submission of applications by Genmab A/S to the U.S. Patent and Trademark Office (USPTO). EPKINLY, . . .
This determination is part of the ongoing process to assess patent term restoration, following the submission of applications by Genmab A/S to the U.S. Patent and Trademark Office (USPTO). EPKINLY, . . .