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FDA grants BTD for Venclexta in combination with azacitidine to treat patients with myelodysplastic syndromes
expresspharma
July 22, 2021
Every year, approximately 10,000 people are diagnosed with myelodysplastic syndromes (MDS) in the US, and there remains a high unmet need for new treatment options.
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Magenta slips after FDA hold on early-stage trial of MGTA-117 in AML, MDS
firstwordpharma
July 22, 2021
Magenta Therapeutics said Wednesday that it has received an FDA clinical hold letter regarding the investigational new drug application it filed in June to start a Phase I/II trial of MGTA-117 in patients with acute myeloid leukaemia (AML) and myelodyspla
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Antengene's Partner Karyopharm Therapeutics Announces Updated Data of Eltanexor in Patients with Hypomethylating Agent Refractory MDS
prnasia
June 09, 2021
Antengene's Partner, Karyopharm Therapeutics Inc., announced updated data of eltanexor for the treatment of patients with hypomethylating agent (HMA) refractory myelodysplastic syndrome (MDS) at the 2021 American Society of Clinical Oncology (ASCO) ...
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Approval of Phase I/II Clinical Trial of ATG-016 (Eltanexor), a Second Generation Selective Inhibitor of Nuclear Export (SINE), in Mainland China for the Treatment of Myelodysplastic Syndrome
prnasia
November 26, 2020
Antengene Corporation Limited, a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-inclass therapeutics in hematology and oncology, announced that the ...
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Gilead gets FDA breakthrough therapy status for magrolimab in MDS
pharmaceutical-business-review
September 18, 2020
Gilead Sciences has been given breakthrough therapy designation for magrolimab from the US Food and Drug Administration (FDA) for the treatment of myelodysplastic syndrome (MDS) in newly diagnosed patients.
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FDA Approves Decitabine, Cedazuridine Oral Combination for MDS
americanpharmaceuticalreview
July 17, 2020
The Food and Drug Administration (FDA) approved an oral combination of decitabine and cedazuridine (INQOVI, Astex Pharmaceuticals, Inc.) for adult patients with myelodysplastic syndromes (MDS) including the following.
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EC clears new class of anaemia therapy
pharmatimes
June 29, 2020
The European Commission has approved BMS’ blood disease therapy Reblozyl (luspatercept) for the treatment of transfusion-dependent anaemia associated with myelodysplastic syndromes (MDS) or beta thalassaemia.
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Key pipeline advancements to propel myelodysplastic syndromes market to $2.4 bn by 2028: GlobalData
expresspharma
June 29, 2020
Despite the recent surge of development within the MDS space, KOLs argue that the level of unmet need remained dire.
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Bristol Myers Squibb, Acceleron get FDA nod for Reblozyl to treat anaemia with lower-risk MDS
pharmaceutical-business-review
April 07, 2020
Bristol Myers Squibb (BMS) and Acceleron Pharma have secured approval from the US Food and Drug Administration (FDA) for Reblozyl (luspatercept-aamt) to treat anaemia in adults with lower-risk myelodysplastic syndromes (MDS).
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Aprea Receives Fast Track Designation, Orphan Drug Designation for APR-246
americanpharmaceuticalreview
April 17, 2019
Aprea Therapeutics announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to APR-246 for the treatment of patients with MDS having a TP53 mutation.