Hemophilia

• EMA approval · 2025-04-25
  EMA Authorised: Elocta (efmoroctocog alfa) — Swedish Orphan Biovitrum AB (publ)

  The European Medicines Agency authorised Elocta (efmoroctocog alfa) for Hemophilia A; decision date: 25/04/2025.

• EMA approval · 2025-03-07
  EMA Authorised: BeneFIX (nonacog alfa) — Pfizer Europe MA EEIG

  The European Medicines Agency authorised BeneFIX (nonacog alfa) for Hemophilia B.

• EMA approval · 2025-03-05
  EMA Authorised: ReFacto AF (moroctocog alfa) — Pfizer Europe MA EEIG

  The European Medicines Agency authorised ReFacto AF (moroctocog alfa) for the treatment of Hemophilia A. Decision date: 03/03/2025.

• FDA approval · 2024-12-20
  FDA Approved: ALHEMO — Original Application (Novo Nordisk)

  The FDA approved ALHEMO (concizumab) from Novo Nordisk based on the original application, intended to prevent bleeding episodes in patients …

• EMA approval · 2024-12-19
  EMA Authorised: Idelvion (albutrepenonacog alfa) — CSL Behring GmbH

  The European Medicines Agency authorised Idelvion (albutrepenonacog alfa) by CSL Behring for Hemophilia B, marking EU marketing approval; it…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• EMA approval · 2024-12-18
  EMA Authorised: Voncento (human coagulation factor VIII;human von willebrand factor) — CSL Behring GmbH

  The EMA authorised Voncento, a Factor VIII/von Willebrand factor concentrate by CSL Behring, for treatment of Hemophilia A and von Willebran…

• EMA approval · 2024-12-05
  EMA Authorised: Esperoct (turoctocog alfa pegol) — Novo Nordisk A/S

  EMA authorised Esperoct (turoctocog alfa pegol) from Novo Nordisk A/S for the treatment of hemophilia A. The decision date was 21 October 20…

• EMA approval · 2024-11-27
  EMA Authorised: Rixubis (nonacog gamma) — Baxalta Innovations GmbH

  The European Medicines Agency authorised Rixubis (nonacog gamma) by Baxalta Innovations GmbH for the treatment of Hemophilia B.

• FDA approval · 2024-03-21
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (Aurobindo Pharma Limited)

  FDA approved desmopressin acetate from Aurobindo Pharma Limited under an original abbreviated new drug application (ANDA213095).

• EMA approval · 2023-03-21
  EMA Authorised: Vihuma (simoctocog alfa) — Octapharma AB

  EMA authorises Vihuma (simoctocog alfa) for Hemophilia A.

• EMA approval · 2023-03-21
  EMA Authorised: Nuwiq (simoctocog alfa) — Octapharma AB

  The EMA authorised Nuwiq (simoctocog alfa) for Hemophilia A, with Octapharma AB as the marketing authorization holder.

• EMA approval · 2023-02-27
  EMA Authorised: NovoSeven (eptacog alfa (activated)) — Novo Nordisk A/S

  The EMA authorised NovoSeven (eptacog alfa activated) from Novo Nordisk A/S for multiple indications including Hemophilia A/B, Factor VII de…

• EMA approval · 2022-11-29
  EMA Authorised: Cevenfacta (Eptacog beta (activated)) — Laboratoire Francais du Fractionnement et des Biotechnologies

  The EMA authorised Cevenfacta (eptacog beta activated) for treatment of bleeding in Hemophilia A and B.

• FDA approval · 2022-11-16
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (Fresenius Kabi USA, LLC)

  FDA approved the Original Application for Desmopressin Acetate from Fresenius Kabi USA, LLC (ANDA216922). This marks the approval of a gener…

• FDA approval · 2022-08-19
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved Desmopressin Acetate from Dr. Reddy's Laboratories Inc. via an Original Application for a generic product.

• EMA approval · 2022-06-24
  First gene therapy to treat severe haemophilia A

  The European Medicines Agency announces the first gene therapy approved to treat severe haemophilia A, marking a landmark advancement in cur…

• FDA approval · 2022-06-23
  FDA Approved: TRANEXAMIC ACID — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for tranexamic acid submitted by Mylan Institutional LLC. This action authorizes the continued comme…

• FDA approval · 2022-06-06
  FDA Approved: HEMLIBRA — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Hemlibra (emicizumab) submitted by Genentech, Inc. The action updates the product’s labeling and…

• FDA approval · 2021-09-02
  FDA Approved: HEMLIBRA — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Hemlibra (emicizumab) from Genentech, expanding or updating its label.

• EMA approval · 2021-05-19
  EMA Authorised: NovoEight (turoctocog alfa) — Novo Nordisk A/S

  NovoEight (turoctocog alfa) by Novo Nordisk A/S has been authorised for use in Hemophilia A.

• FDA approval · 2021-02-12
  FDA Approved: AMINOCAPROIC ACID — Original Application (Biocon Pharma Inc.)

  FDA approved Biocon Pharma Inc.'s aminocaproic acid from an original application (ANDA213928), making it an approved generic therapy to trea…

• FDA approval · 2021-01-26
  FDA Approved: AMINOCAPROIC ACID — Original Application (Biocon Pharma Inc.)

  FDA approves Biocon Pharma Inc.'s aminocaproic acid as an original ANDA, authorizing its marketing as an antifibrinolytic to help control or…

• FDA approval · 2020-02-14
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (Dr.Reddys' Laboratories Inc)

  FDA approved an original application for Desmopressin Acetate from Dr. Reddy's Laboratories Ltd., a generic version of desmopressin acetate.

• FDA approval · 2019-10-24
  FDA Approved: DESMOPRESSIN ACETATE — Supplemental Application (Apotex Corp.)

  FDA approves Apotex Corp.'s supplemental application for Desmopressin Acetate, enabling the generic version to be marketed.

• FDA approval · 2019-08-23
  FDA Approved: AMINOCAPROIC ACID — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a generic aminocaproic acid product from Amneal Pharmaceuticals NY LLC under an Original Application (ANDA 212780). This repres…