Chronic Lymphocytic Leukemia

• FDA approval · 2022-07-06
  FDA Approved: ZYDELIG — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for ZYDELIG (idelalisib) submitted by Gilead Sciences, Inc. The specific changes to the product'…

• FDA approval · 2022-06-03
  FDA Approved: RIABNI — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for RIABNI (rituximab-arrx) from Amgen. The action updates RIABNI’s labeling to reflect its approved…

• FDA approval · 2022-05-11
  FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)

  FDA approved a supplemental application for IMBRUVICA (ibrutinib) from Pharmacyclics LLC.

• FDA approval · 2022-05-11
  FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)

  FDA approves a supplemental application for IMBRUVICA (ibrutinib) submitted by Pharmacyclics LLC. The document indicates FDA approval of the…

• FDA approval · 2022-03-10
  FDA Approved: ZYDELIG — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for ZYDELIG (idelalisib) from Gilead Sciences, Inc. The action updates the labeling for the drug…

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• FDA approval · 2021-12-17
  FDA Approved: COPIKTRA — Supplemental Application (Secura Bio, Inc)

  The FDA has approved a supplemental application for COPIKTRA (duvelisib) by Secura Bio, Inc.

• FDA approval · 2021-12-02
  FDA Approved: RITUXAN — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Rituxan (rituximab) filed by Genentech, Inc., resulting in updated labeling for the product.

• FDA approval · 2021-10-14
  FDA Approved: LENALIDOMIDE — Original Application (Dr. Reddy's Laboratories Inc.)

  The FDA approved Dr. Reddy's Laboratories' original application for lenalidomide (generic), authorizing a generic version of the cancer drug…

• FDA approval · 2021-08-31
  FDA Approved: REVLIMID — Supplemental Application (Celgene Corporation)

  The FDA approved a supplemental application for REVLIMID (lenalidomide) submitted by Celgene Corporation. The action expands or updates the …

• FDA approval · 2021-08-05
  FDA Approved: LENALIDOMIDE — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approved a supplemental application for lenalidomide by Teva Pharmaceuticals, approving changes related to the drug's use.

• FDA approval · 2020-12-17
  FDA Approved: RIABNI — Original Application (Amgen, Inc)

  FDA approved RIABNI (rituximab-arrx) from Amgen as a biosimilar to rituximab via Original Application.

• FDA approval · 2020-08-07
  FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)

  FDA approved a supplemental application for IMBRUVICA (ibrutinib) submitted by Pharmacyclics LLC.

• FDA approval · 2020-05-05
  FDA Approved: RITUXAN HYCELA — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for Rituxan HYCELA (rituximab and hyaluronidase) from Genentech, expanding its approval through …

• FDA approval · 2020-04-21
  FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)

  FDA approved a supplemental application for IMBRUVICA (ibrutinib) submitted by Pharmacyclics LLC.

• FDA approval · 2019-11-26
  FDA Approved: CAMPATH — Supplemental Application (Genzyme Corporation)

  FDA approved a supplemental application for CAMPATH (alemtuzumab) filed by Genzyme Corporation to update the product labeling.

• FDA approval · 2019-11-21
  FDA Approved: TREANDA — Supplemental Application (Cephalon, LLC)

  The FDA approved a supplemental application for TREANDA (bendamustine hydrochloride) submitted by Cephalon, LLC.

• FDA approval · 2019-10-29
  FDA Approved: CAMPATH — Supplemental Application (Genzyme Corporation)

  FDA approved a supplemental application for CAMPATH (alemtuzumab) submitted by Genzyme Corporation. The approval updates the labeling/indica…

• FDA approval · 2019-07-23
  FDA Approved: RUXIENCE — Original Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved Ruxience (rituximab-pvvr) from Pfizer as a biosimilar to rituximab, under an original application; the approval covers multiple…

• FDA approval · 2019-05-23
  FDA Approved: TRUXIMA — Supplemental Application (Cephalon, Inc.)

  FDA approved a supplemental application for TRUXIMA (rituximab-ABBS) submitted by Cephalon, Inc.

• FDA approval · 2019-04-23
  FDA Approved: CAMPATH — Supplemental Application (Genzyme Corporation)

  FDA approved a supplemental application for CAMPATH (alemtuzumab) submitted by Genzyme Corporation.

• FDA approval · 2019-01-18
  FDA Approved: CYCLOPHOSPHAMIDE — Original Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s original application for a generic cyclophosphamide product. This marks approval of a generic formulation …

• FDA approval · 2019-01-16
  FDA Approved: CAMPATH — Supplemental Application (Genzyme Corporation)

  FDA overview of a supplemental application for CAMPATH (alemtuzumab) submitted by Genzyme Corporation.

• FDA approval · 2018-02-06
  FDA Approved: ZYDELIG — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for ZYDELIG (idelalisib) filed by Gilead Sciences, Inc.

• FDA approval · 2018-01-26
  FDA Approved: ZYDELIG — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for ZYDELIG (idelalisib) by Gilead Sciences, Inc.

• FDA approval · 2017-06-22
  FDA Approved: RITUXAN HYCELA — Original Application (Genentech, Inc.)

  FDA approved RITUXAN HYCELA (rituximab and hyaluronidase) under an Original Application by Genentech. The subcutaneous formulation provides …