Polycythemia Vera

• EMA approval · 2026-04-24
  EMA Authorised: Besremi (ropeginterferon alfa-2b) — AOP Orphan Pharmaceuticals GmbH

  The EMA authorised Besremi (ropeginterferon alfa-2b) for the treatment of polycythemia vera; decision date 24 April 2026.

• 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…

• EMA approval · 2025-11-05
  EMA Authorised: Pegasys (peginterferon alfa-2a) — pharmaand GmbH

  EMA authorised Pegasys (peginterferon alfa-2a) for chronic hepatitis C, chronic hepatitis B, polycythemia vera, and essential thrombocythemi…

• 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 · 2024-04-29
  FDA Approved: BESREMI — Supplemental Application (PharmaEssentia USA)

  The FDA approved a supplemental application for BESREMI (ropeginterferon alfa-2b) submitted by PharmaEssentia USA.

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• 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 · 2021-11-12
  FDA Approved: BESREMI — Original Application (PharmaEssentia USA)

  The FDA approved Besremi (ropeginterferon alfa-2b-nnqv) from PharmaEssentia USA for adults with polycythemia vera who require treatment, und…

• 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 · 2017-12-18
  FDA Approved: DROXIA — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for DROXIA (hydroxyurea) submitted by Waylis Therapeutics LLC.

• FDA approval · 2016-03-23
  FDA Approved: DROXIA — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for DROXIA (hydroxyurea) filed by Waylis Therapeutics LLC.

• 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 · 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 · 2006-09-19
  FDA Approved: DROXIA — Supplemental Application (Waylis Therapeutics LLC)

  FDA approves a supplemental application for DROXIA (hydroxyurea) submitted by Waylis Therapeutics LLC.

• FDA approval · 2006-08-15
  FDA Approved: HYDROXYUREA — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental application for HYDROXYUREA submitted by Endo USA, Inc.

• FDA approval ·
  FDA Approves First Drug of Its Kind for Polycythemia Vera, a Rare Blood Disorder

  FDA approves Mimrylo (rusfertide) as the first drug of its kind for adults with polycythemia vera, a rare blood disorder causing excess red …