Chemotherapy-induced Neutropenia
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-03-24EMA Authorised: Grasustek (pegfilgrastim) — Juta Pharma GmbH
EMA authorised Grasustek (pegfilgrastim) for marketing by Juta Pharma GmbH; decision date 24 March 2026.
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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 · 2026-02-19EMA 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 · 2026-01-20EMA Authorised: Nyvepria (pegfilgrastim) — Pfizer Europe MA EEIG
EMA has authorised Nyvepria (pegfilgrastim) for use as a pegfilgrastim product. It is indicated to reduce the duration of chemotherapy-induc…
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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 · 2025-11-25EMA Authorised: Accofil (filgrastim) — Accord Healthcare S.L.U.
The European Medicines Agency authorised Accofil, a filgrastim biosimilar from Accord Healthcare S.L.U., for EU marketing to prevent chemoth…
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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 · 2025-04-18FDA 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 · 2023-10-09FDA Approved: ZIEXTENZO — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for ZIEXTENZO (pegfilgrastim-bmez) filed by Sandoz Inc, indicating a labeling update or indicati…
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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.
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FDA approval · 2023-03-03FDA Approved: UDENYCA — Supplemental Application (Accord BioPharma, Inc.)
The FDA approved a supplemental application for UDENYCA (pegfilgrastim-cbqv) by Accord BioPharma, Inc., to update the product labeling.
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FDA approval · 2022-05-26FDA Approved: FYLNETRA — Original Application (Amneal Pharmaceuticals LLC)
FDA approves FYLNETRA (pegfilgrastim) from Amneal as an original biologics license application to help reduce the duration of neutropenia in…
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FDA approval · 2022-02-25FDA Approved: RELEUKO — Original Application (Amneal Pharmaceuticals LLC)
FDA approved RELEUKO (filgrastim) from Amneal Pharmaceuticals LLC under an Original Application (BLA 761082).
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FDA approval · 2021-06-07FDA Approved: UDENYCA — Supplemental Application (Accord BioPharma, Inc.)
FDA approved a supplemental application for UDENYCA (pegfilgrastim-cbqv) from Accord BioPharma, Inc., under the biosimilars program.
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FDA approval · 2020-06-10FDA Approved: NYVEPRIA — Original Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved NYVEPRIA (pegfilgrastim-APGF) from Pfizer in an original biologics application, establishing a pegfilgrastim biosimilar therapy…
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FDA approval · 2020-02-12FDA Approved: UDENYCA — Supplemental Application (Accord BioPharma, Inc.)
FDA approved a supplemental Biologics License Application for UDENYCA (pegfilgrastim-cbqv) submitted by Accord BioPharma, Inc., expanding it…
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FDA approval · 2019-10-17FDA Approved: UDENYCA — Supplemental Application (Accord BioPharma, Inc.)
FDA approved a supplemental application for UDENYCA (pegfilgrastim-CBQV) submitted by Accord BioPharma, Inc. This action approves changes as…
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FDA approval · 2019-04-16FDA Approved: UDENYCA — Supplemental Application (Accord BioPharma, Inc.)
FDA approved a supplemental application for UDENYCA (pegfilgrastim-cbqv) from Accord BioPharma, authorizing a new or expanded use for the pr…
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FDA approval · 2018-11-02FDA Approved: UDENYCA — Original Application (Accord BioPharma, Inc.)
FDA approved UDENYCA (pegfilgrastim-cbqv) as an original biologics license application for reducing the duration of neutropenia in patients …
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FDA approval · 2018-07-31FDA Approved: GRANIX — Supplemental Application (Cephalon, LLC)
FDA approved a supplemental application for GRANIX (TBO-FILGRASTIM) submitted by Cephalon, LLC.
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FDA approval · 2017-06-21FDA Approved: GRANIX — Supplemental Application (Cephalon, LLC)
FDA approved a supplemental application for GRANIX (TBO-FILGRASTIM) submitted by Cephalon, LLC. The approval updates GRANIX's regulatory sta…
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FDA approval · 2017-02-02FDA Approved: GRANIX — Supplemental Application (Cephalon, LLC)
FDA approved a supplemental application for GRANIX (tbo-filgrastim) submitted by Cephalon, LLC.