U.S. Food and Drug Administration Approval: Ofatumumab for the Treatment of Patients with Chronic Lymphocytic Leukemia Refractory to Fludarabine and Alemtuzumab [PDF]
Steven J. Lemery +11 more
openalex +1 more source
Urinary LGALS3BP is elevated in bladder cancer patients compared to healthy controls as detected by the 1959 antibody–based ELISA. The antibody shows enhanced reactivity to the high‐mannose glycosylated variant secreted by cancer cells treated with kifunensine (KIF).
Asia Pece +18 more
wiley +1 more source
Measurable residual disease (MRD) as a surrogate end point for clinical drug approval in acute myeloid leukemia (AML): Perspectives from the MRD Partnership and Alliance in AML Clinical Treatment Consortium. [PDF]
Boyiadzis M +20 more
europepmc +1 more source
Federal Advisory Committees, Policy Expertise, and the Approval of Drugs and Medical Devices at the FDA [PDF]
Stéphane Lavertu, David L. Weimer
openalex +1 more source
ClinicalTrials.gov and Drugs@FDA: A Comparison of Results Reporting for New Drug Approval Trials
Lisa M. Schwartz +4 more
semanticscholar +1 more source
Intein‐based modular chimeric antigen receptor platform for specific CD19/CD20 co‐targeting
CARtein is a modular CAR platform that uses split inteins to splice antigen‐recognition modules onto a universal signaling backbone, enabling precise, scarless assembly without re‐engineering signaling domains. Deployed here against CD19 and CD20 in B‐cell malignancies, the design supports flexible multi‐antigen targeting to boost T‐cell activation and
Pablo Gonzalez‐Garcia +9 more
wiley +1 more source
The evolutionary safety of mutagenic drugs should be assessed before drug approval. [PDF]
Lobinska G +4 more
europepmc +1 more source
Clinical Trial Design and Drug Approval in Oncology: A Primer for the Advanced Practitioner in Oncology. [PDF]
Kurtin SE, Taher R.
europepmc +1 more source
Identifying prognostic targets in metastatic prostate cancer beyond AR
Genome‐wide functional screens combined with a large gene expression database and clinical outcomes can identify new therapeutic vulnerabilities in prostate cancer. Eight potentially druggable targets demonstrated strong dependency in cell lines, were associated with worse prognosis clinically, and showed evidence of protein expression in prostate ...
Emily Feng +13 more
wiley +1 more source
Machine Learning with Statistical Imputation for Predicting Drug Approval
Andrew W. Lo +2 more
doaj +1 more source

