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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
352
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
439
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
216
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
370
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
172
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
145
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
192
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
168
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
130
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
119
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
127
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
138
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
119
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
169
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
66
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
57
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
89
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
142
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