Neutropenia
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-08-14EMA Authorised: Fulphila (pegfilgrastim) — Biosimilar Collaborations Ireland Limited
The EMA authorises Fulphila (pegfilgrastim) as a biosimilar, granting marketing authorization to Biosimilar Collaborations Ireland Limited.
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EMA approval · 2026-07-14EMA Authorised: Dyrupeg (pegfilgrastim) — CuraTeQ Biologics (Malta) Limited
Dyrupeg (pegfilgrastim) has been authorised by the EMA for neutropenia and cancer indications.
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EMA approval · 2026-07-14EMA Authorised: Zefylti (filgrastim) — CuraTeQ Biologics (Malta) Limited
Zefylti (filgrastim) has been authorised by EMA for use in neutropenia, hematopoietic stem cell transplantation, and cancer indications.
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EMA approval · 2026-03-18EMA Authorised: Cegfila (previously Pegfilgrastim Mundipharma) (pegfilgrastim) — Mundipharma Corporation (Ireland) Limited
The EMA authorised the pegfilgrastim product Cegfila (Mundipharma) for marketing in the European Union.
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EMA approval · 2026-03-18EMA Authorised: Pelmeg (pegfilgrastim) — Mundipharma Corporation (Ireland) Limited
EMA authorised Pelmeg, a pegfilgrastim biosimilar by Mundipharma, to reduce the duration of neutropenia and the risk of febrile neutropenia …
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EMA approval · 2026-03-02EMA Authorised: Nivestim (filgrastim) — Pfizer Europe MA EEIG
EMA has authorized Nivestim (filgrastim) from Pfizer Europe MA EEIG as a biosimilar to treat neutropenia in cancer patients and in the conte…
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EMA approval · 2026-02-24EMA Authorised: Vivlipeg (pegfilgrastim) — Biosimilar Collaborations Ireland Limited
The EMA authorised Vivlipeg, a biosimilar pegfilgrastim. The product is indicated for neutropenia and related febrile neutropenia in cancer …
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EMA approval · 2026-02-19EMA Authorised: Fulphila (pegfilgrastim) — Biosimilar Collaborations Ireland Limited
EMA authorised Fulphila, a pegfilgrastim biosimilar by Biosimilar Collaborations Ireland Limited. The approval covers its use to reduce the …
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EMA approval · 2025-12-08EMA Authorised: Neulasta (pegfilgrastim) — Amgen Europe B.V.
EMA authorised Neulasta (pegfilgrastim) by Amgen Europe B.V. to reduce the risk of neutropenia, febrile neutropenia, and chemotherapy-induce…
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FDA approval · 2025-11-28FDA Approved: ARMLUPEG — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved ARMLUPEG (pegfilgrastim-unne) from Lupin Pharmaceuticals in an Original Biologics License Application. Pegfilgrastim-unne is a …
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EMA approval · 2025-09-29EMA Authorised: Zefylti (filgrastim) — CuraTeQ Biologics s.r.o
The European Medicines Agency authorised Zefylti (filgrastim) as a biosimilar for neutropenia, hematopoietic stem cell transplantation, and …
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FDA approval · 2025-08-21FDA Approved: ZARXIO — Supplemental Application (Sandoz Inc.)
The FDA approved a supplemental application for Zarxio (filgrastim-sndz) submitted by Sandoz Inc. The action concerns updates under a supple…
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EMA approval · 2025-08-12EMA Authorised: Dyrupeg (pegfilgrastim) — CuraTeQ Biologics s.r.o
EMA authorises Dyrupeg (pegfilgrastim) by CuraTeQ Biologics for use in neutropenia and cancer indications.
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EMA approval · 2025-07-08EMA Authorised: Filgrastim Hexal (filgrastim) — Hexal AG
EMA authorised Filgrastim Hexal (filgrastim), a biosimilar granulocyte colony-stimulating factor, for neutropenia management in cancer patie…
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EMA approval · 2025-07-08EMA Authorised: Zarzio (filgrastim) — Sandoz GmbH
The EMA authorised Zarzio, a filgrastim biosimilar from Sandoz GmbH, for use in hematopoietic stem cell transplantation and cancer indicatio…
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FDA approval · 2025-04-29FDA Approved: RELEUKO — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for RELEUKO (filgrastim) from Amneal Pharmaceuticals LLC. This reflects regulatory action on a suppl…
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FDA approval · 2025-04-18FDA Approved: NEUPOGEN — Supplemental Application (Amgen, Inc)
FDA approved a supplemental application for NEUPOGEN (filgrastim) by Amgen, Inc.
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FDA approval · 2025-03-26FDA Approved: STIMUFEND — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for STIMUFEND (PEGFLILGRASTIM-FPGK) from Fresenius Kabi USA, LLC, expanding/confirming labeling to s…
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FDA approval · 2024-10-22FDA Approved: ZARXIO — Supplemental Application (Sandoz Inc.)
FDA approved a supplemental application for Zarxio (filgrastim-sndz) from Sandoz, expanding the biosimilar's approved indications.
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EMA approval · 2024-08-30EMA Authorised: Ratiograstim (filgrastim) — Ratiopharm GmbH
EMA authorised Ratiograstim (filgrastim) by Ratiopharm GmbH for cancer and hematopoietic stem cell transplantation to reduce chemotherapy-in…
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FDA approval · 2024-08-09FDA Approved: ZARXIO — Supplemental Application (Sandoz Inc.)
FDA approved a supplemental application for Zarxio (filgrastim-sndz) submitted by Sandoz Inc. Zarxio is a biosimilar to filgrastim used to m…
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FDA approval · 2024-01-19FDA Approved: ZARXIO — Supplemental Application (Sandoz Inc.)
FDA approved a supplemental application for Zarxio (filgrastim-sndz) filed by Sandoz Inc., resulting in labeling changes under the supplemen…
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FDA approval · 2023-10-13FDA Approved: FULPHILA — Supplemental Application (Biocon Biologics Inc.)
FDA approved a supplemental Biologics License Application for FULPHILA (pegfilgrastim-jmdb) by Biocon Biologics Inc.
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FDA approval · 2023-09-01FDA Approved: RELEUKO — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved a supplemental application for RELEUKO (filgrastim) submitted by Amneal Pharmaceuticals LLC.
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FDA approval · 2023-08-28FDA Approved: NIVESTYM — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for NIVESTYM (filgrastim-aafi) from Pfizer Laboratories Div Pfizer Inc.