FDA
SGX301 is a novel, first-in-class, photodynamic therapy utilizing visible light for activation.
The FDA has approved the new tablet formulation of acalabrutinib for CLL, SLL, and R/R MCL.
The FDA has granted Fast Track Designation and Rare Pediatric Disease Designation for WU-CART-007.
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The phase Ib clinical trial is being launched by Cellenkos in partnership with Incyte as part of their LIMBER initiative.
The U.S. Food and Drug Administration cleared an investigational new drug application for ACE1831, an anti-CD20 armed ...
QXL138AM is a masked immunocytokine comprised of a CD138-targeted antibody fused with...
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Mocravimod is a synthetic, sphingosine 1-phosphate receptor modulator that has been assessed in phase I and II trials.
The use of the CD38-directed monoclonal antibody daratumumab was associated with ocular events...
Mocravimod is a synthetic, sphingosine 1-phosphate receptor (S1PR) modulator.
The FDA has cleared the IND application for LAVA-051, humanized Gammabody designed to activate...
The FDA and Finnish Medicines Agency cleared the investigational new drug application for bexmarilimab.
LAVA-051 consists of two single domain antibodies linked via a short five amino acid glycine-serine linker.
Umbralisib was approved to treat marginal zone lymphoma (MZL) and follicular lymphoma (FL).
The U.S. Food and Drug Administration (FDA) has granted tisagenlecleucel accelerated approval for adult patients with ...
The FDA approval was based on data from the AZA-JMML trial, which observed half of patients reach confirmed responses.
Tasquinimod is an oral immunomodulatory and antiangiogenic investigational treatment.
The phase I/II study will assess the safety and tolerability of the drug.
The hold was initiated after a reported death of a trial participant.
The FDA previously approved this treatment for adults with R/R LBCL or FL who received two or more lines of systemic therapy.
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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