Luspatercept Under Review for Nontransfusion Dependent Beta Thalassemia
The application is supported by data from the phase 2 BEYOND study.
Diagnosis & Disease Information
FDA Unable to Approve Narsoplimab for HSCT-TMA Without More Data
Narsoplimab is a human monoclonal antibody that specifically targets mannan-binding lectin-associated serine protease-2.
Jakafi Approved for Chronic Graft-vs-Host Disease
The approval was based on data from the phase 3 REACH3 study which included 329 patients.
Voxelotor Gets Priority Review for Pediatric Sickle Cell Disease
The sNDA and NDA are supported by data from the open-label phase 2a HOPE-KIDS1 study.
Abatacept Gets Priority Review for Moderate to Severe Acute Graft vs Host Disease
The supplemental Biologics License Application is supported by data from the phase 2 ABA2 trial (ClinicalTrials.gov Identifier: NCT01743131) and real world evidence from a registry trial.
Mitapivat Granted Priority Review for Pyruvate Kinase Deficiency
Mitapivat is a first-in-class, oral, selective small molecule allosteric activator of pyruvate kinase-R enzymes.
FDA Denies Approval of Roxadustat for Anemia in CKD
The FDA noted that the application could not be approved in its present form and had requested an additional clinical study be conducted.
Manufacturing Deficiencies Delay Decision on Eflapegrastim
Eflapegrastim is a novel, long-acting G-CSF comprised of 2 protein components, an analogue of G-CSF and an Fc antibody fragment.
Neulasta Ad Claims Misleading, May Undermine Biosimilar Use, Says FDA
The ad claims that there is a higher risk of febrile neutropenia when pegfilgrastim is administered via prefilled syringe vs Neulasta Onpro on-body injector.
Ayvakit Approved for Advanced Systemic Mastocytosis
The approval was based on data from 2 multicenter, single-arm, open-label clinical trials that evaluated Ayvakit in 53 patients with advanced systemic mastocytosis.
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