Multiple Myeloma
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Sign up freeTop drugs studied for this disease
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FDA approval · 2022-05-02FDA Approved: BORTEZOMIB — Original Application (Apotex Corp)
FDA approves Apotex Corp's original application for a generic Bortezomib product under ANDA205533.
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FDA approval · 2022-05-02FDA Approved: BORTEZOMIB — Original Application (Eugia US LLC)
The FDA approved the original application for a generic Bortezomib product from Eugia US LLC (ANDA212825).
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FDA approval · 2022-05-02FDA Approved: BORTEZOMIB — Original Application (Fresenius Kabi USA, LLC)
FDA approves Fresenius Kabi USA's generic bortezomib injection under Original Application. Indications include multiple myeloma and mantle c…
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FDA approval · 2022-05-02FDA Approved: BORTEZOMIB — Original Application (BluePoint Laboratories)
FDA approved a generic version of bortezomib under an Original Application (ANDA210824) by BluePoint Laboratories.
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FDA approval · 2022-05-02FDA Approved: BORTEZOMIB — Original Application (Zydus Pharmaceuticals USA Inc.)
FDA approved the original application for generic bortezomib by Zydus Pharmaceuticals USA Inc., enabling a generic version of the proteasome…
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FDA approval · 2022-04-28FDA 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 · 2022-04-26FDA Approved: EVOMELA — Supplemental Application (Acrotech Biopharma Inc)
FDA approved a supplemental application for EVOMELA (melphalan liposome injection) filed by Acrotech Biopharma Inc., updating the product la…
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FDA approval · 2022-04-05FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Sagent Pharmaceuticals)
The FDA approved a supplemental application for Zoledronic acid submitted by Sagent Pharmaceuticals, updating regulatory labeling per the su…
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EMA approval · 2022-03-25New gene therapy to treat adult patients with multiple myeloma
EMA announces a new gene therapy approved to treat adult patients with multiple myeloma.
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FDA approval · 2022-03-22FDA Approved: EMPLICITI — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
The FDA approved a supplemental application for EMPLICITI (elotuzumab) from E.R. Squibb & Sons, L.L.C.
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EMA approval · 2021-12-17EMA Authorised: Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka) (lenalidomide hydrochloride monohydrate) — Krka, d.d., Novo mesto
EMA authorised lenalidomide Krka d.d. Novo mesto for indications including multiple myeloma and follicular lymphoma, establishing its market…
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FDA approval · 2021-11-30FDA Approved: DARZALEX FASPRO — Supplemental Application (Janssen Biotech, Inc.)
FDA approved a supplemental application for DARZALEX FASPRO submitted by Janssen Biotech, Inc. to modify/expand its labeling or indication.
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FDA approval · 2021-11-04FDA Approved: VELCADE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Velcade (bortezomib) submitted by Takeda Pharmaceuticals America, Inc. This approval covers …
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FDA approval · 2021-10-14FDA Approved: LENALIDOMIDE — Original Application (Dr. Reddy's Laboratories Inc.)
The FDA approved Dr. Reddy's Laboratories' original application for lenalidomide (generic), authorizing a generic version of the cancer drug…
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FDA approval · 2021-08-31FDA Approved: REVLIMID — Supplemental Application (Celgene Corporation)
The FDA approved a supplemental application for REVLIMID (lenalidomide) submitted by Celgene Corporation. The action expands or updates the …
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FDA approval · 2021-08-09FDA Approved: EVOMELA — Supplemental Application (Acrotech Biopharma Inc)
FDA approves a supplemental application for EVOMELA (melphalan) from Acrotech Biopharma Inc.
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FDA approval · 2021-08-05FDA Approved: LENALIDOMIDE — Supplemental Application (Teva Pharmaceuticals, Inc.)
FDA approved a supplemental application for lenalidomide by Teva Pharmaceuticals, approving changes related to the drug's use.
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FDA approval · 2021-08-05FDA Approved: POMALYST — Supplemental Application (Celgene Corporation)
The FDA approved a supplemental application for POMALYST (pomalidomide) submitted by Celgene Corporation.
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FDA approval · 2021-07-09FDA 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.
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FDA approval · 2021-07-09FDA Approved: DARZALEX — Supplemental Application (Janssen Biotech, Inc.)
The FDA approved a supplemental application for DARZALEX (daratumumab) filed by Janssen Biotech, Inc., resulting in an updated labeling.
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EMA approval · 2021-06-25First cell-based gene therapy to treat adult patients with multiple myeloma
EMA announces first cell-based gene therapy authorized to treat adult patients with multiple myeloma, marking a milestone in advanced cellul…
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FDA approval · 2021-05-28FDA Approved: POMALIDOMIDE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for pomalidomide by Aurobindo Pharma Limited under the ANDA process.
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FDA approval · 2021-04-30FDA Approved: CARMUSTINE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approved a supplemental application for Carmustine submitted by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. This actio…
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FDA approval · 2021-03-31FDA Approved: SARCLISA — Supplemental Application (Sanofi-Aventis U.S. LLC)
FDA approved a supplemental application for SARCLISA (isatuximab) from Sanofi-Aventis U.S. LLC. The action signifies an expanded or updated …
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FDA approval · 2021-03-18FDA Approved: SARCLISA — Supplemental Application (Sanofi-Aventis U.S. LLC)
FDA lists a supplemental application for Sarclisa (isatuximab) from Sanofi-Aventis U.S. LLC.