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Editas Medicine Announces First Quarter 2023 Results and Business Updates

Company to provide a clinical update on the EDIT-301 Phase 1/2 RUBY trial for SCD in June at the European Hematology Association Congress and in a Company-sponsored webinar On track to dose 20. | May 5, 2023

United kingdomUnited statesNew yorkLas vegasLinea aspesiGemma reeveVivo hemoglobinopathiesGilmore oneillEuropean hematology associationBusiness development other corporateShoreline biosciences incExchange commissionBroad instituteHarvard university casDrug administrationHealth care conference

You should read the following discussion and analysis of our financial condition and results of operations together with our Unaudited Condensed Consolidated Financial Statements and related notes. | May 4, 2023

United statesAmerican society of clinical oncologyAmerican society of hematologyEuropean hematology association congressSilicon valley bankJjdc incProtagonist therapeutics incExchange commissionDeposit insurance corporationJanssen biotech incDevelopment expensesFederal reserveSecurities exchangeAudited consolidated financial statementsAnnual reportQuarterly report

FDA Extends Review Period for Quizartinib for Adults With FLT3-ITD-Positive AML

Daiichi Sankyo announced that the new deadline for review of the application is July 24, 2023.

United statesDaiichi sankyoMark rutsteinMikkael sekeresUniversity of miami health systemAmerican cancer societyEuropean hematology association congressOncology clinical developmentPrescription drug user fee actRisk evaluationMitigation strategiesAmerican cancerGlobal headHematology association congressSylvester comprehensive cancer centerMiami health system

FDA Extends Review for Quizartinib in Newly Diagnosed FLT3-ITD+ AML

The FDA has extended the review period for a new drug application for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of newly diagnosed adult patients with FLT3-ITD–positive acute myeloid leukemia.

Mark rutsteinDaiichi sankyoEuropean hematology association congressOncology clinical development at daiichi sankyoPrescription drug user fee actOncology clinical developmentHematology association congressAcute myeloid leukemiaFlt3 itd positive acute myeloid leukemia

Milestone for gene-edited therapy exa-cel for sickle cell disease

Vertex and CRISPR Therapeutics have announced that the EMA has validated the MAA of exa-cel for the treatment of sickle cell disease.

European hematology association congressEuropean medicines agencyEuropean commissionDrug administrationVertex pharmaceuticals europeVertex pharmaceuticalsMarketing authorization applicationNia tatsisOrphan drug designationPriority medicinesBiologics license applicationNew england journal

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