FDA Determines Regulatory Review Period for LAMZEDE for Patent Extension
May 10, 2025
May 10, 2025
WASHINGTON, May 10 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has determined the regulatory review period for the human biologic product LAMZEDE (velmanase alfa-tycv), which is indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in both adult and pediatric patients.
This determination is a significant step for Chiesi Farmaceutici S.p.A., which has applied to the U.S. Patent and Trademark . . .
This determination is a significant step for Chiesi Farmaceutici S.p.A., which has applied to the U.S. Patent and Trademark . . .