Chronic Lymphocytic Leukemia

• CLINICAL_TRIALS approval · 2017-03-20
  Clinical Trial Update: Early Access Program (EAP) for Ibrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

  An Early Access Program for ibrutinib in relapsed or refractory chronic lymphocytic leukemia has been approved for marketing.

• 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…

• 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…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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 · 2014-09-05
  FDA Approved: CAMPATH — Supplemental Application (Genzyme Corporation)

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

• 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…

• EMA approval · 2014-05-23
  European Medicines Agency recommends approval of Gazyvaro for chronic lymphocytic leukaemia

  The European Medicines Agency recommends approval of Gazyvaro for chronic lymphocytic leukemia, supporting its use for this indication.

• 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 · 2009-10-16
  FDA Approved: RITUXAN — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Rituxan (rituximab) from Genentech.

• FDA approval · 2009-03-30
  FDA Approved: CAMPATH — Supplemental Application (Genzyme Corporation)

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

• 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 …