Small Lymphocytic 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 · 2017-06-22
  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 …

• FDA approval · 2017-02-06
  FDA Approved: BENDEKA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

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

• FDA approval · 2016-09-21
  FDA Approved: ZYDELIG — Supplemental Application (Gilead Sciences, Inc.)

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

• 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…

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• FDA approval · 2016-04-11
  FDA Approved: VENCLEXTA — Original Application (AbbVie Inc.)

  FDA approved the original application for VENCLEXTA (venetoclax) by AbbVie. The approval covers the treatment of chronic lymphocytic leukemi…

• 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 · 2015-11-05
  FDA Approved: TREANDA — Supplemental Application (Cephalon, LLC)

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

• 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 · 2014-07-23
  FDA Approved: ZYDELIG — Original Application (Gilead Sciences, Inc.)

  FDA approved ZYDELIG (idelalisib) from Gilead Sciences as a new molecular therapy for adults with relapsed or refractory follicular lymphoma…

• FDA approval · 2014-03-27
  FDA Approved: TREANDA — Supplemental Application (Cephalon, LLC)

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

• FDA approval · 2013-11-01
  FDA Approved: GAZYVA — Original Application (Genentech, Inc.)

  FDA approved GAZYVA (obinutuzumab) from Genentech in its original application for the treatment of chronic lymphocytic leukemia, in combinat…

• 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 …

• FDA approval · 2007-10-15
  FDA Approved: FLUDARABINE — Original Application (Fresenius Kabi USA, LLC)

  FDA approved the original application for Fludarabine phosphate (generic fludarabine) from Fresenius Kabi USA, LLC. The approval covers use …