Graft-versus-host Disease

• EMA approval · 2026-08-25
  EMA Authorised: Rezurock (belumosudil mesilate) — Sanofi Winthrop Industrie

  EMA authorised Rezurock (belumosudil mesilate) for graft-versus-host disease with conditional approval; Orphan medicine designation.

• EMA approval · 2026-04-17
  EMA Authorised: Rezurock (belumosudil mesilate) — Sanofi Winthrop Industrie

  The European Medicines Agency authorised Rezurock (belumosudil mesilate) for graft-versus-host disease under conditional approval and orphan…

• EMA approval · 2026-01-30
  New medicine to treat chronic graft-versus-host disease

  The European Medicines Agency has approved Rezurock (belumosudil) for adults with chronic graft-versus-host disease after failure or intoler…

• FDA approval · 2026-01-21
  FDA Approved: CYCLOSPORINE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved Upsher-Smith's original ANDA for generic cyclosporine.

• FDA approval · 2026-01-15
  FDA Approved: REZUROCK — Supplemental Application (Kadmon Pharmaceuticals, LLC)

  The FDA approved a supplemental application for REZUROCK (belumosudil) submitted by Kadmon Pharmaceuticals, LLC.

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• EMA approval · 2025-11-10
  EMA Authorised: Jakavi (ruxolitinib phosphate) — Novartis Europharm Limited

  Jakavi (ruxolitinib phosphate) has been authorised in the EU with indications for polycythemia vera and graft-versus-host disease. The decis…

• FDA approval · 2025-10-21
  FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)

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

• FDA approval · 2024-12-30
  FDA Approved: REZUROCK — Supplemental Application (Kadmon Pharmaceuticals, LLC)

  The FDA approved a supplemental NDA for REZUROCK (belumosudil) from Kadmon Pharmaceuticals, LLC.

• FDA approval · 2024-08-14
  FDA Approved: NIKTIMVO — Original Application (Incyte Corporation)

  FDA approved NIKTIMVO (axatilimab-csfr) from Incyte in an original Biologics License Application for the treatment of chronic graft-versus-h…

• FDA approval · 2024-05-21
  FDA Approved: CYCLOSPORINE — Original Application (Devatis Inc.)

  FDA approved Devatis Inc.'s cyclosporine as a generic drug under an original ANDA (ANDA209811).

• FDA approval · 2024-04-10
  FDA Approved: REZUROCK — Supplemental Application (Kadmon Pharmaceuticals, LLC)

  FDA approved a supplemental application for REZUROCK (belumosudil) submitted by Kadmon Pharmaceuticals, LLC, expanding its labeled use for c…

• FDA approval · 2024-02-22
  FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)

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

• FDA approval · 2023-12-14
  FDA Approved: CYCLOSPORINE — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approves Teva Pharmaceuticals' generic cyclosporine under an original application (ANDA 203880), expanding access to this immunosuppress…

• FDA approval · 2023-11-09
  FDA Approved: REZUROCK — Supplemental Application (Kadmon Pharmaceuticals, LLC)

  FDA approved a supplemental application for REZUROCK (belumosudil) from Kadmon Pharmaceuticals, LLC.

• FDA approval · 2023-01-19
  FDA Approved: BRUKINSA — Supplemental Application (BeOne Medicines USA, Inc.)

  FDA approved a supplemental application for BRUKINSA (zanubrutinib) submitted by BeOne Medicines USA, Inc.

• FDA approval · 2022-12-19
  FDA Approved: JAKAFI — Supplemental Application (Incyte Corporation)

  FDA approved a supplemental application for Jakafi (ruxolitinib) submitted by Incyte Corporation, resulting in an expanded/updated label und…

• FDA approval · 2022-08-24
  FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)

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

• FDA approval · 2022-05-11
  FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)

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

• FDA approval · 2022-05-11
  FDA Approved: IMBRUVICA — Supplemental Application (Pharmacyclics LLC)

  FDA approves a supplemental application for IMBRUVICA (ibrutinib) submitted by Pharmacyclics LLC. The document indicates FDA approval of the…

• FDA approval · 2022-02-02
  FDA Approved: CYCLOSPORINE — Original Application (Mylan Pharmaceuticals Inc.)

  The FDA approved Mylan Pharmaceuticals' original application for cyclosporine, a generic immunosuppressant product. This makes a generic cyc…

• FDA approval · 2021-07-16
  FDA Approved: REZUROCK — Original Application (Kadmon Pharmaceuticals, LLC)

  The FDA approved REZUROCK (belumosudil) from Kadmon Pharmaceuticals, LLC as an original NDA for the treatment of adults with chronic graft-v…

• FDA approval · 2021-07-16
  FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for PROGRAF (tacrolimus) from Astellas Pharma US, expanding or updating its labeling and indications…

• FDA approval · 2021-03-19
  FDA Approved: UVADEX — Supplemental Application (Therakos LLC)

  FDA approved a supplemental application for UVADEX (methoxsalen) from Therakos LLC.

• 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.