FDA Announces Regulatory Review Period Determination for ELAHERE Patent Extension
May 17, 2025
May 17, 2025
WASHINGTON, May 17 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has issued a notice regarding the regulatory review period determination for the human biological product ELAHERE (mirvetuximab soravtansine-gynx), as published in the Federal Register on May 19, 2025.
ELAHERE, developed by ImmunoGen, Inc., is indicated for the treatment of adult patients with folate receptor alpha positive, platinum-resistant epithelial ovarian, fallopi . . .
ELAHERE, developed by ImmunoGen, Inc., is indicated for the treatment of adult patients with folate receptor alpha positive, platinum-resistant epithelial ovarian, fallopi . . .