Mantle Cell Lymphoma

• FDA approval · 2022-05-02
  FDA Approved: BORTEZOMIB — Original Application (Eugia US LLC)

  The FDA approved the original application for a generic Bortezomib product from Eugia US LLC (ANDA212825).

• FDA approval · 2022-05-02
  FDA Approved: BORTEZOMIB — Original Application (Fresenius Kabi USA, LLC)

  FDA approves Fresenius Kabi USA's generic bortezomib injection under Original Application. Indications include multiple myeloma and mantle c…

• FDA approval · 2022-05-02
  FDA Approved: BORTEZOMIB — Original Application (BluePoint Laboratories)

  FDA approved a generic version of bortezomib under an Original Application (ANDA210824) by BluePoint Laboratories.

• FDA approval · 2022-05-02
  FDA Approved: BORTEZOMIB — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original application for generic bortezomib by Zydus Pharmaceuticals USA Inc., enabling a generic version of the proteasome…

• 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.

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• FDA approval · 2021-11-04
  FDA Approved: VELCADE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for Velcade (bortezomib) submitted by Takeda Pharmaceuticals America, Inc. This approval covers …

• 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.

• EMA approval · 2020-10-16
  First CAR-T cell medicine for mantle cell lymphoma

  The EMA announces the first CAR-T cell medicine approved for mantle cell lymphoma, marking a milestone in targeted cellular therapy for this…

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

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

• FDA approval · 2018-02-16
  FDA Approved: IMBRUVICA — Original Application (Pharmacyclics LLC)

  FDA approved IMBRUVICA (ibrutinib) under the Original Application (NDA210563) for mantle cell lymphoma.

• 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 · 2017-10-31
  FDA Approved: CALQUENCE — Original Application (AstraZeneca Pharmaceuticals LP)

  FDA approved CALQUENCE (acalabrutinib) from the original application by AstraZeneca Pharmaceuticals LP. This marks the initial approval of a…

• FDA approval · 2017-06-09
  FDA Approved: VELCADE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for Velcade (bortezomib) filed by Takeda Pharmaceuticals America, Inc., expanding or modifying i…

• FDA approval · 2016-06-23
  FDA Approved: BENDEKA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Bendeka (bendamustine hydrochloride) submitted by Teva Pharmaceuticals USA, Inc., indicating reg…

• FDA approval · 2016-03-21
  FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)

  FDA approved a supplemental application for IMBRUVICA (ibrutinib) filed by Pharmacyclics LLC. The document indicates FDA action on a supplem…

• FDA approval · 2015-07-08
  FDA Approved: TREANDA — Supplemental Application (Cephalon, LLC)

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

• FDA approval · 2014-02-12
  FDA Approved: IMBRUVICA — Original Application (Pharmacyclics LLC)

  The FDA granted the original approval of Imbruvica (ibrutinib) to Pharmacyclics LLC under NDA205552, marking its first approval for mantle c…

• FDA approval · 2013-11-13
  FDA Approved: IMBRUVICA — Original Application (Pharmacyclics LLC)

  FDA approved IMBRUVICA (ibrutinib) under its Original Application (NDA205552) for mantle cell lymphoma.

• FDA approval · 2012-06-26
  FDA Approved: TREANDA — Supplemental Application (Cephalon, LLC)

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

• FDA approval · 2011-12-21
  FDA Approved: REVLIMID — Supplemental Application (Celgene Corporation)

  The FDA approves a supplemental application for Revlimid (lenalidomide) submitted by Celgene Corporation, updating regulatory status for the…

• FDA approval · 2010-10-12
  FDA Approved: REVLIMID — Supplemental Application (Celgene Corporation)

  FDA approved a supplemental application for REVLIMID (lenalidomide) submitted by Celgene Corporation.

• FDA approval · 2010-02-26
  FDA Approved: TREANDA — Supplemental Application (Cephalon, LLC)

  The FDA approved a supplemental application for TREANDA (bendamustine hydrochloride) from Cephalon, LLC, enabling revisions to its labeling …