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Incyte to Highlight Data From its Oncology Portfolio at the 2024 ASCO Annual Meeting and EHA2024 Congress

Incyte to Highlight Data From its Oncology Portfolio at the 2024 ASCO Annual Meeting and EHA2024 Congress
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United statesSteven steinEuropean hematology associationEuropean medicines agencyMyeloproliferative neoplasms biology translational researchDrug administrationExchange commissionIncyte corporationAmerican society of clinical oncologyMyeloproliferative neoplasms biology transitional researchXencor incLymphoma biology translational researchClinical oncologyAnnual meetingChief medical officerSelect advanced solid tumors

Akebia Receives FDA Approval of Vafseo® (vadadustat) Tablets for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients on Dialysis

Akebia Receives FDA Approval of Vafseo® (vadadustat) Tablets for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients on Dialysis
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United statesUnited kingdomGlennm chertowLori hartwellJohnp butlerClin nephrolDivision of nephrology at stanford universityRenal support networkDrug administrationNational institutes of healthNational institute of diabetesExchange commissionAkebia therapeutics incClin lab haematolSteering committeeCompany to host conference call on

FDA Approves Vadadustat (Vafseo) Tablets for Anemia Due to CKD in Adult Patients on Dialysis

FDA Approves Vadadustat (Vafseo) Tablets for Anemia Due to CKD in Adult Patients on Dialysis
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United statesJohnp butlerDrug administrationAkebia therapeuticsComplete response letterBoxed warningNew drug applicationPrescription drug user fee actFormal dispute resolution requestChronic kidney diseaseAdult patientsAnemia dueVadadustat resubmission

Vafseo® approved by the U S FDA for the treatment of anemia due to chronic kidney disease in dialysis-dependent adult patients

/PRNewswire/ CSL Vifor is pleased that its partner Akebia Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved.

United statesThomas hutterGlennm chertowClin nephrolSteering committeeDrug administrationFresenius medical careVifor internationalAkebia therapeutics incNational institute of diabetesClin lab haematolNational institutes of healthDivision of nephrology at stanford universityAkebia therapeuticsGeneral managerStanford university

FDA Drug Approval Decisions Expected in March 2024

The PDUFA date refers to the deadline set by the US Food and Drug Administration for reviewing drug applications.

Atidarsagene autotemcelDrug administrationPrescription drug user fee actNew drug applicationBiologics license applicationPriority reviewNonalcoholic steatohepatitisWith liverPulmonary arterialAnemia dueChronic kidney