Acute Lymphoblastic Leukemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-10-29FDA Approved: CYCLOPHOSPHAMIDE — Original Application (Nexus Pharmaceuticals, LLC)
FDA approved Nexus Pharmaceuticals, LLC to market a generic cyclophosphamide product under Original Application ANDA216783.
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FDA approval · 2024-10-23FDA Approved: JYLAMVO — Supplemental Application (SHORLA ONCOLOGY INC.)
The FDA approved a supplemental application for JYLAMVO (methotrexate) filed by SHORLA ONCOLOGY INC.
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FDA approval · 2024-07-31FDA Approved: PHYRAGO — Supplemental Application (Cycle Pharmaceuticals Ltd)
The FDA approved a supplemental application for PHYRAGO (dasatinib) from Cycle Pharmaceuticals Ltd, indicating an update to the product's la…
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FDA approval · 2024-07-09FDA Approved: MERCAPTOPURINE — Supplemental Application (Nova Laboratories, Ltd)
The FDA approved a supplemental application for mercaptopurine (Purixan) by Nova Laboratories, Ltd., updating the product labeling and/or in…
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FDA approval · 2024-07-09FDA Approved: MERCAPTOPURINE — Supplemental Application (Florida Pharmaceutical Products, LLC)
FDA approved a supplemental application for Mercaptopurine submitted by Florida Pharmaceutical Products, LLC.
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FDA approval · 2024-06-03FDA Approved: METHOTREXATE — Original Application (Alembic Pharmaceuticals Inc.)
FDA approved Alembic Pharmaceuticals' original application for methotrexate, authorizing the generic version of the drug.
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FDA approval · 2024-04-15FDA Approved: RYLAZE — Supplemental Application (Jazz Pharmaceuticals, Inc.)
The FDA approved a supplemental application for RYLAZE (asparaginase Erwinia chrysanthemi recombinant) submitted by Jazz Pharmaceuticals, In…
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FDA approval · 2024-03-13FDA Approved: ONCASPAR — Supplemental Application (Servier Pharmaceuticals LLC)
FDA approved a supplemental application for ONCASPAR (pegaspargase) submitted by Servier Pharmaceuticals LLC.
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FDA approval · 2024-03-06FDA Approved: BESPONSA — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
The FDA approved a supplemental application for BESPONSA (inotuzumab ozogamicin) submitted by Wyeth Pharmaceuticals LLC, a subsidiary of Pfi…
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FDA approval · 2024-03-01FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for GLEEVEC (imatinib mesylate) submitted by Novartis Pharmaceuticals Corporation. This action confi…
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FDA approval · 2024-01-05FDA Approved: IMATINIB MESYLATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application from Mylan Pharmaceuticals for imatinib mesylate, enabling a generic version to be marketed under AN…
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FDA approval · 2023-09-22FDA Approved: DASATINIB — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for dasatinib by Apotex Corp. The approval allows the generic product to be marketed.
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FDA approval · 2023-08-29FDA Approved: CLOFARABINE — Supplemental Application (Dr.Reddy's Laboratories Inc)
FDA approved a supplemental application for clofarabine from Dr. Reddy's Laboratories Inc, marking an approved update to the generic drug's …
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FDA approval · 2023-08-16FDA Approved: IMATINIB — Supplemental Application (Dr.Reddy's Laboratories Inc)
FDA approved a supplemental application for Imatinib from Dr. Reddy's Laboratories Inc, resulting in regulatory approval for a change to the…
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FDA approval · 2023-06-20FDA Approved: BLINCYTO — Supplemental Application (Amgen, Inc)
The FDA approved Amgen's supplemental application for BLINCYTO (blinatumomab), updating the product's labeling and/or indication.
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FDA approval · 2023-06-15FDA Approved: CYTARABINE — Supplemental Application (Meitheal Pharmaceuticals Inc.)
FDA approved a supplemental application for Cytarabine from Meitheal Pharmaceuticals Inc., completing a modification to the existing Cytarab…
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FDA approval · 2023-02-08FDA Approved: DASATINIB — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for Dasatinib submitted by Prasco Laboratories. The action approves an additional submission under N…
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FDA approval · 2023-01-31FDA Approved: IMATINIB MESYLATE — Supplemental Application (BluePoint Laboratories)
FDA approves a supplemental application for Imatinib Mesylate from BluePoint Laboratories under an ANDA, confirming approval of a generic pr…
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FDA approval · 2023-01-09FDA Approved: CLOFARABINE — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for clofarabine (CLOFARABINE) from Mylan Institutional LLC, expanding the regulatory approval for th…
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FDA approval · 2022-12-22FDA Approved: ONCASPAR — Supplemental Application (Servier Pharmaceuticals LLC)
The FDA approved a supplemental application for ONCASPAR (pegaspargase) submitted by Servier Pharmaceuticals LLC.
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FDA approval · 2022-12-05FDA Approved: BLINCYTO — Supplemental Application (Amgen, Inc)
The FDA approved a supplemental application for BLINCYTO (blinatumomab) submitted by Amgen, expanding its regulatory scope.
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FDA approval · 2022-11-29FDA Approved: JYLAMVO — Original Application (SHORLA ONCOLOGY INC.)
FDA approved JYLAMVO (methotrexate) under an Original Application from SHORLA ONCOLOGY INC.
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FDA approval · 2022-11-18FDA Approved: RYLAZE — Supplemental Application (Jazz Pharmaceuticals, Inc.)
The FDA approved Jazz Pharmaceuticals' supplemental application for RYLAZE (ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN). The appro…
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FDA approval · 2022-10-03FDA Approved: CLOFARABINE — Original Application (Eugia US LLC)
FDA approved the original ANDA for clofarabine, manufactured by Eugia US LLC.
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FDA approval · 2022-06-21FDA Approved: IMATINIB MESYLATE — Original Application (Upsher-Smith Laboratories, LLC)
FDA approved an original application for imatinib mesylate (Upsher-Smith Laboratories) as a generic product. The approval supports its use f…