Gastrointestinal Stromal Tumor

• FDA approval · 2013-09-13
  FDA Approved: STIVARGA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for Stivarga (regorafenib) submitted by Bayer HealthCare Pharmaceuticals Inc.

• FDA approval · 2013-08-30
  FDA Approved: SUTENT — Supplemental Application (U.S. Pharmaceuticals)

  The FDA overview notes a supplemental application for Sutent (sunitinib malate) submitted by U.S. Pharmaceuticals. The submission status is …

• FDA approval · 2013-01-25
  FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for GLEEVEC (imatinib mesylate) submitted by Novartis, reflecting changes to the product labeling.

• CLINICAL_TRIALS approval · 2012-03-09
  Clinical Trial Update: A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248

  Pfizer's SU011248 (sunitinib) for gastrointestinal stromal tumor has been approved for marketing.

• FDA approval · 2008-12-19
  FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for GLEEVEC (imatinib mesylate) from Novartis Pharmaceuticals Corporation, resulting in regulatory a…

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• FDA approval · 2007-09-13
  FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA supplemental application submitted for GLEEVEC (imatinib mesylate) by Novartis Pharmaceuticals Corporation.

• FDA approval · 2006-10-19
  FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for GLEEVEC (imatinib mesylate) submitted by Novartis Pharmaceuticals Corporation.