Myelofibrosis

• EMA approval · 2026-08-19
  EMA Authorised: Inrebic (fedratinib dihydrochloride monohydrate) — Bristol Myers Squibb Pharma EEIG

  The EMA authorises Inrebic (fedratinib dihydrochloride monohydrate) for myeloproliferative disorders, including primary myelofibrosis, with …

• FDA approval · 2026-03-18
  FDA Approved: OJJAARA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for OJJAARA (momelotinib) from GlaxoSmithKline LLC.

• EMA approval · 2026-01-13
  EMA Authorised: Inrebic (fedratinib dihydrochloride monohydrate) — Bristol Myers Squibb Pharma EEIG

  The European Medicines Agency authorised Inrebic for myeloproliferative neoplasms, including primary myelofibrosis, with Bristol Myers Squib…

• FDA approval · 2025-10-01
  FDA Approved: VONJO — Supplemental Application (Sobi, Inc.)

  The FDA approved a supplemental application for VONJO (pacritinib) from Sobi, Inc., expanding its labeling for the treatment of adults with …

• FDA approval · 2025-08-22
  FDA Approved: VONJO — Supplemental Application (Sobi, Inc.)

  FDA approved a Supplemental Application for Vonjo (pacritinib) from Sobi, Inc., updating the product labeling.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• EMA approval · 2025-05-12
  EMA Authorised: Omjjara (Momelotinib dihydrochloride monohydrate) — GlaxoSmithKline Trading Services Limited

  The European Medicines Agency authorized Omjjara (momelotinib dihydrochloride monohydrate) for myeloproliferative disorders including myelof…

• FDA approval · 2025-05-12
  FDA Approved: INREBIC — Supplemental Application (Celgene Corporation)

  The FDA approved a supplemental application for INREBIC (fedratinib hydrochloride) submitted by Celgene Corporation.

• FDA approval · 2024-11-12
  FDA Approved: VONJO — Supplemental Application (Sobi, Inc.)

  FDA approved a supplemental application for VONJO (pacritinib) by Sobi, Inc.

• FDA approval · 2024-09-23
  FDA Approved: HYDROXYUREA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for Hydroxyurea, confirming an updated approval for the generic produ…

• FDA approval · 2024-07-30
  FDA Approved: INREBIC — Supplemental Application (Celgene Corporation)

  FDA approved a supplemental application for INREBIC (fedratinib hydrochloride) from Celgene Corporation (NDA 212327).

• FDA approval · 2023-09-15
  FDA Approved: OJJAARA — Original Application (GlaxoSmithKline LLC)

  FDA approved OJJAARA (momelotinib) from GlaxoSmithKline in an original application for the treatment of myelofibrosis.

• 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 · 2022-02-28
  FDA Approved: VONJO — Original Application (Sobi, Inc.)

  FDA approved VONJO (pacritinib) from Sobi, Inc. as the original NDA approval for the treatment of adults with myelofibrosis, including patie…

• FDA approval · 2021-12-03
  FDA Approved: INREBIC — Supplemental Application (Celgene Corporation)

  FDA supplemental application for INREBIC (fedratinib hydrochloride) submitted by Celgene Corporation; this entry documents a regulatory acti…

• FDA approval · 2021-11-23
  FDA Approved: INREBIC — Supplemental Application (Celgene Corporation)

  FDA approved a supplemental application for INREBIC (fedratinib hydrochloride) from Celgene Corporation.

• 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 · 2019-08-16
  FDA Approved: INREBIC — Original Application (Celgene Corporation)

  FDA approved INREBIC (fedratinib hydrochloride) from Celgene as an original application for adults with myelofibrosis.

• 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 · 2014-05-30
  FDA Approved: JAKAFI — Supplemental Application (Incyte Corporation)

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

• FDA approval · 2013-06-12
  FDA Approved: JAKAFI — Supplemental Application (Incyte Corporation)

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

• 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 · 2011-11-16
  FDA Approved: JAKAFI — Original Application (Incyte Corporation)

  The FDA granted original approval for JAKAFI (ruxolitinib) by Incyte Corporation, marking the first approval of this drug for the treatment …