FDA

Cecilia BrownT-Cell Lymphoma | August 25, 2022
SGX301 is a novel, first-in-class, photodynamic therapy utilizing visible light for activation.
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Leah SherwoodChronic Lymphocytic Leukemia | August 16, 2022
The FDA has approved the new tablet formulation of acalabrutinib for CLL, SLL, and R/R MCL.
Leah SherwoodTransplantation & Cellular Therapy | July 29, 2022
The FDA has granted Fast Track Designation and Rare Pediatric Disease Designation for WU-CART-007.
Leah SherwoodTransplantation & Cellular Therapy | July 20, 2022
The U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application from Cellenkos, Inc. to ...
Leah SherwoodAggressive B-Cell Lymphoma | July 15, 2022
The U.S. Food and Drug Administration cleared an investigational new drug application for ACE1831, an anti-CD20 armed ...
Leah SherwoodMyeloma | July 6, 2022
QXL138AM is a masked immunocytokine comprised of a CD138-targeted antibody fused with...
Leah SherwoodAcute Myeloid Leukemia | June 29, 2022
Mocravimod is a synthetic, sphingosine 1-phosphate receptor modulator that has been assessed in phase I and II trials.
Leah LawrenceMyeloma | June 27, 2022
The use of the CD38-directed monoclonal antibody daratumumab was associated with ocular events...
Leah LawrenceAcute Myeloid Leukemia | June 27, 2022
Mocravimod is a synthetic, sphingosine 1-phosphate receptor (S1PR) modulator.
Kerri FitzgeraldAcute Myeloid Leukemia | June 23, 2022
The FDA has cleared the IND application for LAVA-051, humanized Gammabody designed to activate...
Kerri FitzgeraldAcute Myeloid Leukemia | June 23, 2022
The FDA and Finnish Medicines Agency cleared the investigational new drug application for bexmarilimab.
Leah LawrenceChronic Lymphocytic Leukemia | June 23, 2022
LAVA-051 consists of two single domain antibodies linked via a short five amino acid glycine-serine linker.
Leah LawrenceIndolent B-Cell Lymphoma | June 8, 2022
Umbralisib was approved to treat marginal zone lymphoma (MZL) and follicular lymphoma (FL).
Leah LawrenceIndolent B-Cell Lymphoma | June 8, 2022
The U.S. Food and Drug Administration (FDA) has granted tisagenlecleucel accelerated approval for adult patients with ...
Leah LawrenceAcute Myeloid Leukemia | May 26, 2022
The FDA approval was based on data from the AZA-JMML trial, which observed half of patients reach confirmed responses.
Leah LawrenceMyeloproliferative Neoplasms | May 26, 2022
Tasquinimod is an oral immunomodulatory and antiangiogenic investigational treatment.
Leah LawrenceChronic Myeloid Leukemia | May 26, 2022
The phase I/II study will assess the safety and tolerability of the drug.
Leah LawrenceAcute Myeloid Leukemia | May 26, 2022
The hold was initiated after a reported death of a trial participant.
Kerri FitzgeraldAggressive B-Cell Lymphoma | May 24, 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 | May 24, 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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