Multiple Myeloma
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Sign up freeTop drugs studied for this disease
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EMA approval · 2025-01-06EMA Authorised: Pomalidomide Viatris (Pomalidomide) — Viatris Limited
The European Medicines Agency authorised Pomalidomide Viatris for the treatment of multiple myeloma, with EU marketing authorization granted…
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FDA approval · 2024-12-26FDA Approved: CYCLOPHOSPHAMIDE — Original Application (Slate Run Pharmaceuticals, LLC)
FDA approves Slate Run Pharmaceuticals' original application for CYCLOPHOSPHAMIDE FOR INJECTION, expanding the market for a generic cyclopho…
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FDA approval · 2024-12-19FDA Approved: CYCLOPHOSPHAMIDE — Original Application (BluePoint Laboratories)
FDA approved BluePoint Laboratories' original ANDA for cyclophosphamide, establishing a generic version of the chemotherapy agent.
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FDA approval · 2024-12-02FDA Approved: TALVEY — Supplemental Application (Janssen Biotech, Inc.)
FDA approved Janssen Biotech's supplemental application for TALVEY (talquetamab), updating its labeling to reflect the approved changes. TAL…
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FDA approval · 2024-12-02FDA Approved: TECVAYLI — Supplemental Application (Janssen Biotech, Inc.)
FDA approved a supplemental application for TECVAYLI (teclistamab-cqyv) by Janssen Biotech, Inc.
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FDA approval · 2024-11-22FDA Approved: TECVAYLI — Supplemental Application (Janssen Biotech, Inc.)
FDA has approved a supplemental application for TECVAYLI (teclistamab-cqyv) by Janssen Biotech, Inc., potentially updating the labeling or i…
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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 · 2024-10-25FDA Approved: SARCLISA — Supplemental Application (Sanofi-Aventis U.S. LLC)
The FDA approved a supplemental application for SARCLISA (isatuximab) from Sanofi-Aventis U.S. LLC.
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EMA approval · 2024-10-18EMA Authorised: Velcade (bortezomib) — Janssen-Cilag International NV
The EMA authorised Velcade (bortezomib) from Janssen-Cilag International NV for use in multiple myeloma.
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FDA approval · 2024-09-26FDA Approved: POMALIDOMIDE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' original application for pomalidomide (generic pomalidomide).
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FDA approval · 2024-09-20FDA Approved: SARCLISA — Supplemental Application (Sanofi-Aventis U.S. LLC)
The FDA approved a supplemental application for SARCLISA (isatuximab) submitted by Sanofi-Aventis U.S. LLC. The action represents an approva…
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EMA approval · 2024-09-17EMA Authorised: Pomalidomide Accord (Pomalidomide) — Accord Healthcare S.L.U.
EMA authorised Pomalidomide Accord for the treatment of multiple myeloma. This authorisation adds a pomalidomide option to the market from A…
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FDA approval · 2024-09-11FDA Approved: LENALIDOMIDE — Original Application (Novugen Pharma (USA) LLC)
FDA approved the original application for lenalidomide from Novugen Pharma (USA) LLC, enabling a generic version of the cancer drug lenalido…
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FDA approval · 2024-09-10FDA Approved: ELREXFIO — Supplemental Application (U.S. Pharmaceuticals)
The FDA approved a supplemental application for ELREXFIO (elranatamab-BCMM) submitted by U.S. Pharmaceuticals, resulting in updated labeling…
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FDA approval · 2024-08-26FDA Approved: BORUZU — Original Application (Amneal Pharmaceuticals LLC)
FDA approved BORUZU (bortezomib) from Amneal Pharmaceuticals as an original NDA. The approval covers indications including multiple myeloma …
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EMA approval · 2024-07-31EMA Authorised: Mozobil (Plerixafor) — Sanofi B.V.
The EMA authorised Mozobil (plerixafor) from Sanofi B.V. for multiple myeloma and lymphoma indications, including use in hematopoietic stem …
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FDA approval · 2024-07-30FDA Approved: DARZALEX FASPRO — Supplemental Application (Janssen Biotech, Inc.)
The FDA approved a supplemental application for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) from Janssen Biotech, Inc. The notice i…
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FDA approval · 2024-07-02FDA Approved: TALVEY — Supplemental Application (Janssen Biotech, Inc.)
FDA approved a supplemental application for TALVEY (talquetamab) from Janssen Biotech, Inc. The supplemental approval updates the labeling f…
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FDA approval · 2024-07-02FDA Approved: TECVAYLI — Supplemental Application (Janssen Biotech, Inc.)
FDA approved a supplemental application for TECVAYLI (teclistamab-cqyv) from Janssen Biotech, Inc.
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FDA approval · 2024-07-01FDA Approved: NINLARO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for NINLARO (ixazomib) submitted by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2024-06-11FDA Approved: POMALIDOMIDE — Original Application (Apotex Corp.)
FDA approved Apotex Corp.'s original (ANDA) application for pomalidomide, establishing a generic version of the drug. Pomalidomide is indica…
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FDA approval · 2024-05-28FDA Approved: TECVAYLI — Supplemental Application (Janssen Biotech, Inc.)
FDA approved a supplemental application for Tecvayli (teclistamab-cqyv) from Janssen Biotech, Inc.
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FDA approval · 2024-05-16FDA Approved: IMDELLTRA (AMG757) — Original Application (Amgen, Inc)
FDA approved IMDELLTRA (AMG757) from Amgen via an original application; tarlatamab-dlle is approved for treating multiple myeloma.
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EMA approval · 2024-05-13EMA Authorised: Plerixafor Accord (Plerixafor) — Accord Healthcare S.L.U.
EMA authorised Plerixafor Accord for mobilizing hematopoietic stem cells in adults with multiple myeloma undergoing autologous stem cell tra…
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FDA approval · 2024-05-03FDA Approved: PLERIXAFOR — Original Application (Gland Pharma Limited)
FDA approved an original application for a generic version of plerixafor (ANDA206644) from Gland Pharma Limited for stem cell mobilization i…