Acute Lymphoblastic Leukemia

• FDA label_change · 2025-10-21
  FDA Approved: BLINCYTO — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for BLINCYTO (blinatumomab) submitted by Amgen to update the labeling. The change reflects an expand…

• FDA label_change · 2025-01-03
  FDA Approved: DOXORUBICIN HYDROCHLORIDE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for doxorubicin hydrochloride from Zydus Lifesciences Limited, updating the labeling for the product…

• FDA label_change · 2023-11-29
  FDA Approved: ASPARLAS — Supplemental Application (Servier Pharmaceuticals LLC)

  FDA approved a supplemental application for ASPARLAS (calaspargase pegol) from Servier Pharmaceuticals LLC, resulting in changes to the prod…

• FDA label_change · 2016-10-07
  FDA Approved: ONCASPAR — Supplemental Application (Servier Pharmaceuticals LLC)

  FDA approved a Supplemental Application for ONCASPAR (pegaspargase) from Servier Pharmaceuticals LLC, updating the product labeling.

• FDA label_change · 2016-06-02
  FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for ICLUSIG (ponatinib hydrochloride) from Takeda Pharmaceuticals America, Inc. The approval updates…

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• FDA label_change · 2014-08-15
  FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application to update the labeling for ICLUSIG (ponatinib hydrochloride) from Takeda Pharmaceuticals America, In…

• FDA label_change · 2013-12-20
  FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for ICLUSIG (ponatinib hydrochloride) from Takeda Pharmaceuticals America, updating the labeling for…

• FDA label_change · 2013-09-27
  FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tasigna (nilotinib) from Novartis, outlining changes to the drug’s labeling.