Multiple Myeloma
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-05-03FDA Approved: BORTEZOMIB — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' generic Bortezomib through an Original Application (ANDA 212204). This approval makes a generic version…
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FDA approval · 2024-04-11FDA Approved: PLERIXAFOR — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved Amneal Pharmaceuticals LLC's supplemental application for plerixafor (generic) under an ANDA. This action approves a change…
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FDA approval · 2024-03-01FDA 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 · 2024-02-20FDA Approved: TECVAYLI — Supplemental Application (Janssen Biotech, Inc.)
The FDA approved a supplemental application for TECVAYLI (teclistamab-cqyv) filed by Janssen Biotech, Inc., marking an approval action relat…
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FDA approval · 2024-02-05FDA Approved: PLERIXAFOR — Supplemental Application (Meitheal Pharmaceuticals Inc.)
The FDA approved a supplemental application for Plerixafor by Meitheal Pharmaceuticals, granting approval for an additional submission relat…
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FDA approval · 2024-01-30FDA Approved: PLERIXAFOR — Supplemental Application (Dr. Reddy's Laboratories Inc)
FDA approved a supplemental application for plerixafor from Dr. Reddy's Laboratories, typically resulting in a labeling or usage modificatio…
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FDA approval · 2024-01-30FDA Approved: PLERIXAFOR — Supplemental Application (Zydus Lifesciences Limited)
FDA approves a supplemental application for Plerixafor submitted by Zydus Lifesciences Limited.
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FDA approval · 2023-11-16FDA Approved: TECVAYLI — Supplemental Application (Janssen Biotech, Inc.)
FDA approved a supplemental application for TECVAYLI (teclistamab-cqyv) to expand or modify its labeling for the treatment of multiple myelo…
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FDA approval · 2023-11-16FDA Approved: TALVEY — Supplemental Application (Janssen Biotech, Inc.)
The FDA approved a supplemental application for TALVEY (talquetamab) from Janssen Biotech, Inc. The action updates the drug's labeling/indic…
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FDA approval · 2023-11-01FDA Approved: SARCLISA — Supplemental Application (Sanofi-Aventis U.S. LLC)
The FDA approved a supplemental application for Sarclisa (isatuximab) from Sanofi to expand its label for use in multiple myeloma.
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EMA approval · 2023-10-13New treatment option for heavily pre-treated multiple myeloma patients
The EMA announces a new treatment option for heavily pre-treated multiple myeloma patients, expanding options for this difficult-to-treat gr…
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FDA approval · 2023-10-05FDA Approved: LENALIDOMIDE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for lenalidomide submitted by Zydus Pharmaceuticals USA Inc. under ANDA210154, updating the lena…
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FDA approval · 2023-09-08FDA Approved: APHEXDA — Original Application (Gamida Cell Inc.)
FDA approved APHEXDA (motixafortide) from Gamida Cell as a new drug to mobilize hematopoietic stem cells in adults with multiple myeloma or …
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FDA approval · 2023-08-18FDA Approved: IVRA — Original Application (Apotex Corp)
FDA approved Apotex Corp's original application for IVRA, an intravenous melphalan hydrochloride formulation.
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EMA approval · 2023-08-17EMA Authorised: Nexpovio (selinexor) — Stemline Therapeutics B.V.
EU authorization of Nexpovio (selinexor) for multiple myeloma, with Stemline Therapeutics B.V. as MAH, decision dated 14 August 2023.
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FDA approval · 2023-08-14FDA Approved: ELREXFIO — Original Application (U.S. Pharmaceuticals)
FDA approved ELREXFIO (elranatamab-BCMM) via an Original Application for use in adults with multiple myeloma.
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FDA approval · 2023-08-09FDA Approved: TALVEY — Original Application (Janssen Biotech, Inc.)
FDA approves TALVEY (talquetamab) from Janssen Biotech as an original Biologics License Application for adults with multiple myeloma who hav…
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FDA approval · 2023-08-09FDA Approved: TECVAYLI — Supplemental Application (Janssen Biotech, Inc.)
The FDA approved Janssen Biotech's supplemental application for TECVAYLI (teclistamab-cqyv), resulting in an updated/expanded labeling for t…
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FDA approval · 2023-07-26FDA Approved: PLERIXAFOR — Original Application (Zydus Lifesciences Limited)
FDA approved the original generic application for Plerixafor, enabling Zydus Lifesciences Limited to market the drug in the United States.
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FDA approval · 2023-07-24FDA Approved: PLERIXAFOR — Original Application (Meitheal Pharmaceuticals Inc.)
FDA approved a generic version of plerixafor (Meitheal Pharmaceuticals) via an Original Application, enabling broader access for hematopoiet…
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FDA approval · 2023-07-24FDA Approved: PLERIXAFOR — Original Application (Dr. Reddy's Laboratories Inc)
FDA approved the original application for a generic Plerixafor (PLERIXAFOR) manufactured by Dr. Reddy's Laboratories Inc.
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FDA approval · 2023-07-24FDA Approved: PLERIXAFOR — Original Application (Novadoz Pharmaceuticals LLC)
FDA approved a generic version of Plerixafor (Novadoz Pharmaceuticals LLC) under an Original Application (ANDA) for mobilizing hematopoietic…
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FDA approval · 2023-07-24FDA Approved: PLERIXAFOR — Original Application (Eugia US LLC)
FDA approved the original abbreviated new drug application for Plerixafor by Eugia US LLC, enabling its generic entry for stem cell mobiliza…
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FDA approval · 2023-06-05FDA Approved: ZOLEDRONIC ACID — Original Application (Meitheal Pharmaceuticals Inc.)
The FDA approved Meitheal Pharmaceuticals' original application for zoledronic acid, enabling a generic IV bisphosphonate product. This mark…
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FDA approval · 2023-03-24FDA Approved: POMALYST — Supplemental Application (Celgene Corporation)
FDA approved a supplemental application for POMALYST (pomalidomide) from Celgene Corporation.