Multiple Myeloma

• FDA label_change · 2026-02-19
  FDA Approved: ELREXFIO — Supplemental Application (U.S. Pharmaceuticals)

  FDA approved a supplemental application for ELREXFIO (elranatamab-BCMM) from U.S. Pharmaceuticals, resulting in an update to its labeling/in…

• FDA label_change · 2026-01-27
  FDA Approved: DARZALEX FASPRO — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for DARZALEX FASPRO, submitted by Janssen Biotech, Inc. The approval updates the labeling for th…

• FDA label_change · 2024-02-20
  FDA Approved: TALVEY — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for TALVEY (talquetamab) from Janssen Biotech, Inc., resulting in updated labeling for the product.

• FDA label_change · 2023-09-21
  FDA Approved: MOZOBIL — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for MOZOBIL (plerixafor) from Sanofi-Aventis U.S. LLC, updating the drug's labeling.

• FDA label_change · 2022-06-30
  FDA Approved: LENALIDOMIDE — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  FDA approved a supplemental application for lenalidomide submitted by Dr. Reddy's Laboratories Inc., resulting in updated labeling for the d…

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• FDA label_change · 2021-03-12
  FDA Approved: DARZALEX FASPRO — Supplemental Application (Janssen Biotech, Inc.)

  FDA approves a supplemental application for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) by Janssen Biotech, expanding its labeling …

• FDA label_change · 2020-11-20
  FDA Approved: POMALYST — Supplemental Application (Celgene Corporation)

  FDA approved a supplemental application for POMALYST (pomalidomide) by Celgene, resulting in changes to the product labeling.

• FDA label_change · 2019-10-08
  FDA Approved: BENDEKA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Bendeka (bendamustine hydrochloride) by Teva Pharmaceuticals to update its labeling.

• FDA label_change · 2018-03-20
  FDA Approved: POMALYST — Supplemental Application (Celgene Corporation)

  FDA approved a supplemental application for POMALYST (pomalidomide) submitted by Celgene Corporation, resulting in a label change.

• FDA label_change · 2015-10-08
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Sagent Pharmaceuticals)

  FDA supplemental application for Zoledronic Acid submitted by Sagent Pharmaceuticals to modify the drug's labeling.