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FDA Announcements
FDA Approved for RRMM: Sarclisa (isatuximab-irfc) + Kyprolis (Carfilzomib) and Dexamethasone (IKd)
On March 31, 2021, the Food and Drug Administration approved isatuximab-irfc (Sarclisa, sanofi-aventis U.S. LLC) in combination with...
FDA Announcements
Dec 10, 2021
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RRMM:Daratumumab and Hyaluronidase-fihj (Darzalex Faspro) + Pomalidomide (Pomalyst) & Dexamethasone
FDA approved for RRMM: Daratumumab and Hyaluronidase-fihj (Darzalex Faspro) + Pomalidomide (Pomalyst) and Dexamethasone Relapsed &...
FDA Announcements
Dec 9, 2021
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FDA Approved for RRMM:Daratumumab and Hyaluronidase-fihj(Darzalex Faspro) + Kyprolis & Dexamethasone
FDA Approved for RRMM: Daratumumab and Hyaluronidase-fihj (Darzalex Faspro) + Kyprolis & Dexamethasone FDA approves Darzalex Faspro,...
FDA Announcements
Dec 2, 2021
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Abecma: CART Cell Therapy -FDA Approves First Cell-Based Gene Therapy for Adult Patients with RRMM
For Immediate Release: March 27, 2021: The U.S. Food and Drug Administration approved Abecma (idecabtagene vicleucel), a cell-based gene...
FDA Announcements
Dec 1, 2021
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FDA Approved for RRMM: Xpovio (selinexor) tablets + Velcade (Bortezomib) and Dexamethasone
On December 18, 2020, the Food and Drug Administration approved selinexor (XPOVIO, Karyopharm Therapeutics Inc.) in combination with...
FDA Announcements
Dec 18, 2020
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FDA Approved for RRMM: Sarclisa (isatuximab-irfc) + Pomalyst (Pomalidomide) and Dexamethasone (IPd)
On March 2, 2020, the Food and Drug Administration approved isatuximab-irfc (SARCLISA, sanofi-aventis U.S. LLC) in combination with...
FDA Announcements
Dec 10, 2020
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FDA Approved for RRMM: Belantamab mafodotin-blmf
On August 5, 2020, the Food and Drug Administration granted accelerated approval to belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline)...
FDA Announcements
Dec 6, 2020
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FDA Approved for RRMM: Darzalex (Daratumumab) + Kyprolis (Carfilzomib) and Dexamethasone (Dara-Kd)
On August 20, 2020, the Food and Drug Administration approved carfilzomib (KYPROLIS, Onyx Pharmaceuticals, Inc.) and daratumumab...
FDA Announcements
Dec 1, 2020
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FDA Approved for RRMM:Daratumumab and Hyaluronidase-fihj (Darzalex Faspro) + Velcade & Dexamethasone
FDA Approved for RRMM: : Daratumumab and Hyaluronidase-fihj (Darzalex Faspro) + Velcade and Dexamethasone FDA approves daratumumab and...
FDA Announcements
Dec 1, 2020
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Daratumumab / Hyaluronidase-fihj (Darzalex Faspro) + Lenalidomide (Revlimid)+ Dexamethasone for NDMM
NDMM (Transplant ineligible): Daratumumab and Hyaluronidase-fihj (Darzalex Faspro) + Lenalidomide (Revlimid) & Dexamethasone FDA approves...
FDA Announcements
Dec 1, 2020
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Daratumumab and Hyaluronidase-fihj (Darzalex Faspro) + Lenalidomide (Revlimid) & Dex for RRMM
RRMM: Daratumumab and Hyaluronidase-fihj (Darzalex Faspro) + Lenalidomide (Revlimid) & Dexamethasone Relapsed & Refractory Multiple...
FDA Announcements
Dec 1, 2020
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Daratumumab and Hyaluronidase-fihj (Darzalex Faspro) + Velcade, Melphalan and Prednisone
NDMM (Transplant ineligible): Daratumumab and Hyaluronidase-fihj (Darzalex Faspro) + Velcade, Melphalan & Prednisone FDA approves...
FDA Announcements
Dec 1, 2020
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FDA Approved for RRMM: Daratumumab and Hyaluronidase-fihj (Darzalex Faspro) Monotherapy
FDA Approved for RRMM: : Daratumumab and Hyaluronidase-fihj (Darzalex Faspro) Monotherapy FDA approves daratumumab and hyaluronidase-fihj...
FDA Announcements
Dec 1, 2020
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FDA Approved NDMM Transplant Eligible: Daratumumab + Bortezomib, Thalidomide and Dexamethasone
On September 26, 2019, the Food and Drug Administration approved daratumumab (DARZALEX, Janssen) for adult patients with multiple myeloma...
FDA Announcements
Dec 25, 2019
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FDA Approved for NDMM Transp. Ineligible: Daratumumab + Lenalidomide & Dexamethasone
On June 27, 2019, the Food and Drug Administration approved daratumumab (DARZALEX, Janssen Biotech, Inc.) in combination with...
FDA Announcements
Dec 25, 2019
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FDA Approved for RRMM: Xpovio (selinexor) tablets + Dexamethasone
On July 3, 2019, the Food and Drug Administration granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) in...
FDA Announcements
Dec 18, 2019
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FDA Approved for RRMM: Elotuzumab (Empliciti) with Pomalidomide and dexamethasone (Pd)
11/06/2018 : U.S. Food and Drug Administration Approves Empliciti® (elotuzumab) Plus Pomalidomide and Dexamethasone, a New Immunotherapy...
FDA Announcements
Dec 12, 2018
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FDA Approves KYPROLIS® (carfilzomib) Once-Weekly 70 mg/m2 + Dexamethasone (Kd70) in relapsed Myeloma
Oct. 1, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the...
FDA Announcements
Dec 8, 2018
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