FDA

Cecilia BrownT-Cell Lymphoma | November 14, 2022
SGX301 is a novel, first-in-class, photodynamic therapy utilizing visible light for activation.
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Leah SherwoodChronic Lymphocytic Leukemia | February 1, 2023
The FDA has approved the new tablet formulation of acalabrutinib for CLL, SLL, and R/R MCL.
Leah SherwoodTransplantation & Cellular Therapy | November 16, 2022
The FDA has granted Fast Track Designation and Rare Pediatric Disease Designation for WU-CART-007.
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Leah SherwoodTransplantation & Cellular Therapy | April 12, 2023
The phase Ib clinical trial is being launched by Cellenkos in partnership with Incyte as part of their LIMBER initiative.
Leah SherwoodAggressive B-Cell Lymphoma | November 22, 2022
The U.S. Food and Drug Administration cleared an investigational new drug application for ACE1831, an anti-CD20 armed ...
Leah SherwoodMyeloma | November 22, 2022
QXL138AM is a masked immunocytokine comprised of a CD138-targeted antibody fused with...
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Leah SherwoodAcute Myeloid Leukemia | November 14, 2022
Mocravimod is a synthetic, sphingosine 1-phosphate receptor modulator that has been assessed in phase I and II trials.
Leah LawrenceMyeloma | November 22, 2022
The use of the CD38-directed monoclonal antibody daratumumab was associated with ocular events...
Leah LawrenceAcute Myeloid Leukemia | February 2, 2023
Mocravimod is a synthetic, sphingosine 1-phosphate receptor (S1PR) modulator.
Kerri FitzgeraldAcute Myeloid Leukemia | November 16, 2022
The FDA has cleared the IND application for LAVA-051, humanized Gammabody designed to activate...
Kerri FitzgeraldAcute Myeloid Leukemia | February 2, 2023
The FDA and Finnish Medicines Agency cleared the investigational new drug application for bexmarilimab.
Leah LawrenceChronic Lymphocytic Leukemia | November 16, 2022
LAVA-051 consists of two single domain antibodies linked via a short five amino acid glycine-serine linker.
Leah LawrenceIndolent B-Cell Lymphoma | November 14, 2022
Umbralisib was approved to treat marginal zone lymphoma (MZL) and follicular lymphoma (FL).
Leah LawrenceIndolent B-Cell Lymphoma | November 22, 2022
The U.S. Food and Drug Administration (FDA) has granted tisagenlecleucel accelerated approval for adult patients with ...
Leah LawrenceAcute Myeloid Leukemia | February 2, 2023
The FDA approval was based on data from the AZA-JMML trial, which observed half of patients reach confirmed responses.
Leah LawrenceMyelofibrosis | February 8, 2024
Tasquinimod is an oral immunomodulatory and antiangiogenic investigational treatment.
Leah LawrenceChronic Myeloid Leukemia | February 2, 2023
The phase I/II study will assess the safety and tolerability of the drug.
Leah LawrenceAcute Myeloid Leukemia | February 2, 2023
The hold was initiated after a reported death of a trial participant.
Kerri FitzgeraldAggressive B-Cell Lymphoma | November 14, 2022
The FDA previously approved this treatment for adults with R/R LBCL or FL who received two or more lines of systemic therapy.
Kerri FitzgeraldPrint | November 14, 2022
During an April meeting, the FDA’s Oncologic Drugs Advisory Committee voted 16-0 (with one abstention) in support of basing ...
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