Lunsumio Approved for Relapsed or Refractory Follicular Lymphoma
Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody that targets CD20 on the surface of B cells and CD3 on the surface of T cells.
Diagnosis & Disease Information
FDA Approval Updates Enjaymo Indication for Cold Agglutinin Disease
Enjaymo is an immunoglobulin G subclass 4 monoclonal antibody.
Takhzyro Approved for Pediatric Hereditary Angioedema
The approval was supported extrapolation of efficacy data from the phase 3 HELP study, along with safety and pharmacodynamic data from the phase 3 SPRING study.
FDA Approves Autoinjector Presentation of Pegfilgrastim Biosimilar Udenyca
The new autoinjector is designed with push-on-skin activation to be used in both in-office and at-home settings of care.
Jesduvroq Approved for Anemia of CKD in Patients on Dialysis
Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor.
Avapritinib Gets Priority Review for Indolent Systemic Mastocytosis
The sNDA is supported by data from the phase 2 PIONEER trial that evaluated the efficacy and safety of avapritinib in patients with indolent systemic mastocytosis.
Tecartus Approved for Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia
The approval was based on data from the phase 1/2 ZUMA-3 trial which evaluated Tecartus in 71 adults with relapsed or refractory B-cell precursor ALL.
AstraZeneca Will Withdraw Leukemia Drug Lumoxiti From US Market
Lumoxiti was approved by the FDA in September 2018 for the treatment of adults with relapsed or refractory hairy cell leukemia.
First Gene Therapy for Hemophilia B Gets FDA Approval
The approval was based on data from the HOPE-B trial that included 54 male participants with severe or moderately severe hemophilia B.
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