Estrogen Receptor-positive Breast Cancer

• FDA approval · 2025-09-25
  FDA Approved: INLURIYO — Original Application (Eli Lilly and Company)

  FDA approved INLURIYO (imlunestrant) from Eli Lilly in an original NDA, an oral selective estrogen receptor degrader for estrogen receptor–p…

• FDA approval · 2023-11-09
  FDA Approved: ORSERDU — Supplemental Application (Stemline Therapeutics, Inc.)

  The FDA approves a supplemental application for ORSERDU (elacestrant) submitted by Stemline Therapeutics, Inc.

• FDA approval · 2023-01-27
  FDA Approved: ORSERDU — Original Application (Stemline Therapeutics, Inc.)

  FDA approved ORSERDU (elacestrant) for ER-positive, HER2-negative advanced or metastatic breast cancer following aromatase inhibitor therapy…

• FDA approval · 2021-07-29
  FDA Approved: FULVESTRANT — Original Application (Zydus Lifesciences Limited)

  The FDA approved a generic fulvestrant product from Zydus Lifesciences Limited under an Original Application for the treatment of estrogen r…

• FDA approval · 2018-04-27
  FDA Approved: EXEMESTANE — Original Application (Cipla USA Inc.)

  FDA approves Cipla USA Inc.'s generic Exemestane as an original ANDA approval (ANDA 210323).

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