Acute Promyelocytic Leukemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-06-10FDA Approved: TRETINOIN — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Glenmark's supplemental application for tretinoin (generic) under ANDA 208279, authorizing continued or expanded marketing of t…
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CLINICAL_TRIALS research · 2024-06-10Clinical Trial Update: Evaluate the Efficacy and Safety of Interferon-α Combined With ATO in the Treatment of Arsenic-resistant APL [NA]
This clinical trial update tests the efficacy and safety of combining Interferon-α with arsenic trioxide in arsenic-resistant acute promyelo…
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CLINICAL_TRIALS research · 2024-05-10Clinical Trial Update: Optimum Induction Therapy of Low-risk APL [NA]
A clinical trial (NCT05832320) at Peking University People's Hospital is evaluating optimum oral induction therapy for low-risk acute promye…
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FDA approval · 2023-10-11FDA Approved: ARSENIC TRIOXIDE — Supplemental Application (Fresenius Kabi USA, LLC)
The FDA approved a supplemental application for arsenic trioxide submitted by Fresenius Kabi USA, LLC under an existing ANDA.
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FDA approval · 2023-08-22FDA Approved: TRETINOIN — Original Application (Encube Ethicals, Inc.)
FDA approved the original application for tretinoin from Encube Ethicals, Inc., enabling a generic version of tretinoin.
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FDA approval · 2023-04-20FDA Approved: ARSENIC TRIOXIDE — Original Application (Northstar Rx LLC)
Original application approval of Arsenic Trioxide (generic) by Northstar Rx LLC.
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FDA label_change · 2022-10-27FDA Approved: ARSENIC TRIOXIDE — Supplemental Application (Nexus Pharmaceuticals LLC)
The FDA approved a supplemental application for arsenic trioxide filed by Nexus Pharmaceuticals LLC, typically involving labeling or manufac…
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CLINICAL_TRIALS trial_result · 2022-10-12Clinical Trial Update: Phase III Trial in Acute Promyelocytic Leukemia Patients [Phase 3]
Phase III clinical trial in acute promyelocytic leukemia has completed.
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CLINICAL_TRIALS trial_result · 2022-10-04Clinical Trial Update: Oral Arsenic Trioxide for Newly Diagnosed Acute Promyelocytic Leukaemia [Phase 2]
Phase 2 trial investigating oral arsenic trioxide for newly diagnosed acute promyelocytic leukemia is ongoing or results not yet available.
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CLINICAL_TRIALS trial_result · 2021-12-16Clinical Trial Update: Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia [Phase 3]
Phase 3 trial update of tretinoin and arsenic trioxide for untreated acute promyelocytic leukemia; results have been posted and the trial is…
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FDA approval · 2021-12-02FDA Approved: ARSENIC TRIOXIDE — Original Application (Sandoz Inc)
FDA approved the original application for arsenic trioxide from Sandoz Inc., enabling the generic version to reach the market.
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CLINICAL_TRIALS trial_result · 2021-11-30Clinical Trial Update: Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy [Phase 2]
Phase 2 trial evaluating combined tretinoin and arsenic trioxide for newly diagnosed acute promyelocytic leukemia with risk-adapted postremi…
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FDA approval · 2021-11-12FDA Approved: ARSENIC TRIOXIDE — Supplemental Application (Ingenus Pharmaceuticals, LLC)
The FDA approved a supplemental application for arsenic trioxide from Ingenus Pharmaceuticals, LLC.
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FDA approval · 2021-10-15FDA Approved: ARSENIC TRIOXIDE — Original Application (Eugia US LLC)
FDA approved a generic arsenic trioxide product (Eugia US LLC) under an original ANDA. The approval supports use for acute promyelocytic leu…
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FDA approval · 2021-10-07FDA Approved: ARSENIC TRIOXIDE — Original Application (Sagent Pharmaceuticals)
FDA approved the Original Application (ANDA) for arsenic trioxide from Sagent Pharmaceuticals, enabling a generic version of the cancer drug…
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CLINICAL_TRIALS trial_result · 2021-09-08Clinical Trial Update: Treatment of Non-high-risk Acute Promyelocytic Leukemia (APL) With Realgar-Indigo Naturalis Formula (RIF) [Phase 3]
A Phase 3 trial evaluating Realgar-Indigo Naturalis Formula (RIF) for non-high-risk acute promyelocytic leukemia is in early status (phase 3…
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CLINICAL_TRIALS guidance · 2021-03-23Clinical Trial Update: Clinical Guidelines for APL Treatment [Phase 4]
Phase 4 clinical guidelines update for acute promyelocytic leukemia (APL).
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CLINICAL_TRIALS trial_result · 2021-02-21Clinical Trial Update: Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL) [Phase 4]
Phase 4 clinical trial update on cytarabine (Ara-C) in children with acute promyelocytic leukemia (APL) completed; results posted.
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FDA approval · 2021-01-25FDA Approved: ARSENIC TRIOXIDE — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals' arsenic trioxide as an original ANDA, providing a generic injectable for acute promyelocytic leukemia.
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FDA approval · 2020-10-20FDA Approved: TRISENOX — Supplemental Application (Cephalon, LLC)
The FDA approved a supplemental application for Trisenox (arsenic trioxide) submitted by Cephalon, LLC.
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CLINICAL_TRIALS trial_result · 2020-10-14Clinical Trial Update: AIDA 2000 Guidelines [Phase 2]
Phase 2 clinical trial update for Acute Promyelocytic Leukemia under the AIDA 2000 Guidelines.
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CLINICAL_TRIALS trial_result · 2020-06-25Clinical Trial Update: Prevention and Treatment of Differentiation Syndrome in Patients With Acute Promyelocytic Leukemia [Phase 4]
Phase 4 clinical trial update focused on prevention and treatment of differentiation syndrome in acute promyelocytic leukemia.
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FDA approval · 2020-05-15FDA Approved: ARSENIC TRIOXIDE — Supplemental Application (Ingenus Pharmaceuticals, LLC)
FDA approved a supplemental application for arsenic trioxide from Ingenus Pharmaceuticals, LLC, enabling its generic product to be marketed …
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CLINICAL_TRIALS trial_result · 2019-08-19Clinical Trial Update: Combined Retinoic Acid,Arsenic Trioxide and Chemo for Newly-diagnosed APL [Phase 4]
Phase 4 trial update investigating the combination of retinoic acid, arsenic trioxide, and chemotherapy for newly diagnosed acute promyelocy…
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FDA approval · 2019-06-20FDA Approved: TRISENOX — Supplemental Application (Cephalon, LLC)
FDA approved a supplemental application for TRISENOX (arsenic trioxide) submitted by Cephalon, LLC.