Neutropenia
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Sign up freeTop drugs studied for this disease
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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.
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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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CLINICAL_TRIALS trial_result · 2023-01-05Clinical Trial Update: Umbilical Cord Derived Mesenchymal Stem Cells for Treatment-induced Myelosuppression in Hematologic Malignancies [Phase 1, Phase 2]
Phase 1/2 clinical trial evaluating umbilical cord–derived mesenchymal stem cells for treatment-induced myelosuppression in hematologic mali…
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FDA approval · 2022-11-28FDA Approved: UDENYCA — Supplemental Application (Accord BioPharma, Inc.)
The FDA has approved a supplemental application for UDENYCA (pegfilgrastim-cbQV) submitted by Accord BioPharma, Inc.
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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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CLINICAL_TRIALS trial_result · 2022-04-15Clinical Trial Update: Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer [Phase 2]
Phase 2 study of SPI-2012 or Pegfilgrastim for managing neutropenia in breast cancer has completed; results posted in 2022.
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CLINICAL_TRIALS trial_result · 2022-03-02Clinical Trial Update: SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide [Phase 3]
Phase 3 trial comparing SPI-2012 to Pegfilgrastim for neutropenia management in breast cancer patients receiving docetaxel and cyclophospham…
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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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CLINICAL_TRIALS trial_result · 2021-11-05Clinical Trial Update: A Study of Amphotericin B Liposome for Injection in Patients With Persistent Neutropenia and Fever [Phase 3]
Phase 3 clinical trial update for amphotericin B liposome in patients with persistent neutropenia and fever.
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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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CLINICAL_TRIALS trial_result · 2021-05-07Clinical Trial Update: Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy [Phase 3]
Phase 3 trial evaluating F-627 (Neulasta-controlled) in women with breast cancer undergoing myelotoxic chemotherapy has completed and posted…
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CLINICAL_TRIALS withdrawal · 2021-04-27Clinical Trial Update: Fever and Neutropenia in Pediatric Oncology Patients [Phase 3]
A Phase 3 pediatric oncology trial investigating fever and neutropenia has been withdrawn.
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FDA approval · 2021-02-02FDA Approved: NEULASTA — Supplemental Application (Amgen, Inc)
FDA approved a supplemental application for NEULASTA (pegfilgrastim) by Amgen, Inc.
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FDA approval · 2020-11-18FDA Approved: NEULASTA — Supplemental Application (Amgen, Inc)
FDA approved a supplemental application for NEULASTA (pegfilgrastim) submitted by Amgen. The approval updates the product labeling based on …
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CLINICAL_TRIALS trial_result · 2020-11-02Clinical Trial Update: Low-risk Fever and Neutropenia in Children With Cancer: Safety and Efficacy of Oral Antibiotics in an Outpatient Setting [Phase 3]
Phase 3 trial evaluating safety and efficacy of oral antibiotics for low-risk fever and neutropenia in outpatient children with cancer; stud…
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CLINICAL_TRIALS trial_result · 2020-10-28Clinical Trial Update: Efficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer [Phase 4]
Phase 4 trial assessing the efficacy and safety of 4.5 mg PEG-rhG-CSF per cycle to prevent neutropenia after intensive chemotherapy in breas…
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CLINICAL_TRIALS trial_result · 2020-09-24Clinical Trial Update: LIFEMEL Efficacy in Preventing Haematopoietic Toxicity in Patients Treated With Chemotherapy [Phase 2]
A Phase 2 clinical trial update reports on the efficacy of LIFEMEL in preventing hematopoietic toxicity (neutropenia) in patients undergoing…
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CLINICAL_TRIALS trial_result · 2019-12-23Clinical Trial Update: Home Away From Home - Medical Outcomes
Completed clinical trial update for a study involving acute myeloid leukemia and neutropenia with mention of bacteremia results.
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CLINICAL_TRIALS trial_result · 2019-12-06Clinical Trial Update: Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever [Phase 4]
A Phase 4 clinical trial comparing cefepime to ceftazidime as empirical therapy for neutropenic fever has completed.
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CLINICAL_TRIALS trial_result · 2019-11-21Clinical Trial Update: A Pharmacokinetics/Dynamics Ib Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy [Phase 1, Phase 2]
Phase 1/2 pharmacokinetics/dynamics study of F-627 in women with neutropenia undergoing myelotoxic chemotherapy has completed.
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FDA approval · 2019-08-01FDA Approved: ZARXIO — Supplemental Application (Sandoz Inc.)
The FDA approved a supplemental application for Zarxio (filgrastim-sndz) submitted by Sandoz Inc.
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CLINICAL_TRIALS trial_result · 2019-07-26Clinical Trial Update: Safety and Pharmacokinetics of Intravenous and Oral Posaconazole in Immunocompromised Children (MK-5592-097) [Phase 1]
Phase 1 study evaluating safety and pharmacokinetics of intravenous and oral posaconazole in immunocompromised children with neutropenia.
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FDA approval · 2019-05-29FDA Approved: FULPHILA — Supplemental Application (Biocon Biologics Inc.)
FDA approved a supplemental application for Fulphila (pegfilgrastim-jmdb) from Biocon Biologics Inc., expanding its regulatory status.