Graft-versus-host Disease

• FDA approval · 2020-01-14
  FDA Approved: JAKAFI — Supplemental Application (Incyte Corporation)

  FDA approved a supplemental application for JAKAFI (ruxolitinib) submitted by Incyte Corporation, resulting in a label change and/or expande…

• 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 · 2015-10-06
  FDA Approved: JAKAFI — Supplemental Application (Incyte Corporation)

  The FDA approved a supplemental application for Jakafi (ruxolitinib) submitted by Incyte Corporation, resulting in labeling updates.

• FDA approval · 2014-12-15
  FDA Approved: JAKAFI — Supplemental Application (Incyte Corporation)

  The FDA announced a supplemental application submission for JAKAFI (ruxolitinib) by Incyte, indicating a potential supplemental approval. Th…

• FDA approval · 2014-01-16
  FDA Approved: CYCLOSPORINE — Supplemental Application (Apotex Corp)

  The FDA approved a supplemental application for cyclosporine from Apotex Corp, authorizing changes under the generic product's regulatory fi…

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• FDA approval · 2013-09-27
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for CELLCEPT (mycophenolate mofetil) submitted by Genentech.

• FDA approval · 2013-09-27
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for MYCOPHENOLATE MOFETIL by Accord Healthcare Inc., marking an update to its regulatory status rela…

• FDA approval · 2012-06-21
  FDA Approved: JAKAFI — Supplemental Application (Incyte Corporation)

  The FDA approved a supplemental application for JAKAFI (ruxolitinib) submitted by Incyte Corporation.

• 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 ·
  FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patients

  FDA approves TREGZI, the first regulatory T cell–based immunotherapy to improve chronic GVHD-free survival in adults undergoing allo-HSCT fo…