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The BCMA CAR-T Co-developed by Innovent and IASO Was Granted Breakthrough Therapy Designation by the NMPA for the Treatment of Relapsed/Refractory Multiple Myeloma
prnasia
February 23, 2021
Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and IASO Biotherapeutics (IASO Bio) ...
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NICE recommends Revlimid for newly diagnosed multiple myeloma patients
pharmatimes
January 27, 2021
Bristol Myers Squibb’s (BMS) Revlimid (lenalidomide) has received a recommendation from the UK’s National Institute of Health and Care Excellence (NICE) for newly diagnosed multiple myeloma patients.
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Harpoon Therapeutics Granted Orphan Drug Designation for Multiple Myeloma Treatment
americanpharmaceuticalreview
January 20, 2021
Harpoon Therapeutics announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. HPN217, a tri-specific T cell activating recombinant protein construct (TriTAC®) targets ...
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FDA Approves XPOVIO for Multiple Myeloma
americanpharmaceuticalreview
January 07, 2021
Karyopharm Therapeutics announced the U.S. Food and Drug Administration (FDA) has approved XPOVIO® (selinexor), the Company's first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) medicine, in combination with bortezomib and dexamethasone ...
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Gracell Biotechnologies Announces Presentation of First-in-Human Data of GC012F a First-in-Class FasTCAR-enabled Dual-targeting BMCA/CD19 CAR-T Cell Therapy for Patients with Relapsed or Refractory Mu
prnasia
December 07, 2020
Gracell Biotechnologies Inc., a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, announced an interim readout to evaluate the safety and efficacy of ...
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FDA Lifts Hold on Multiple Myeloma Study
americanpharmaceuticalreview
December 03, 2020
Cellectis announced the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Phase 1 MELANI-01 trial evaluating the UCARTCS1 product candidate for the treatment of patients with relapsed or refractory multiple myeloma (MM).
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NICE backs use of new treatment for multiple myeloma
pharmatimes
November 27, 2020
Patients with a difficult to treat form of multiple myeloma will now gain access to a new treatment on the NHS in England and Wales, after cost regulators issued final guidance on the use of Sanofi's Sarclisa (isatuximab).
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NATCO gets US FDA approval for Pomalidomide capsules
expresspharma
November 16, 2020
Natco Pharma announced that its marketing partner, Breckenridge Pharmaceutical, has received final approval for its Abbreviated New Drug Application (ANDA) for Pomalidomide Capsules, from the US Food and Drug Administration {USFDA).
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BioLineRx Announces Positive Results from Trial of Motixafortide in Stem Cell Mobilization
americanpharmaceuticalreview
November 11, 2020
BioLineRx announced positive results from a planned interim analysis of the ongoing GENESIS Phase 3 trial of motixafortide for stem cell mobilization (SCM) in multiple myeloma patients.
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XNK Therapeutics receives US orphan drug status for NK cell-based immunotherapy in multiple myeloma
pharmaceutical-business-review
November 09, 2020
XNK Therapeutics announced it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its leading investigational drug candidate in the treatment of multiple myeloma (MM).