Minimal Residual Disease as an Early Endpoint for Accelerated Drug Approval in Myeloma: A Roadmap. [PDF]
Landgren O, Devlin SM.
europepmc +1 more source
An estimate of rate of deviation from NCCN guideline recommendations for central nervous system imaging in trials forming basis for drug approval in first line advanced non-small cell lung cancer (NSCLC). [PDF]
Sharp J, Prasad V.
europepmc +1 more source
The tumor microenvironment is a dynamic, multifaceted complex system of interdependent cellular, biochemical, and biophysical components. Three‐dimensional in vitro models of the tumor microenvironment enable a better understanding of these interactions and their impact on cancer progression and therapeutic resistance.
Salma T. Rafik+3 more
wiley +1 more source
Critical insights into the evolving drug-approval process in China. [PDF]
Nikanjam M, Kurzrock R.
europepmc +1 more source
New Drug and Biologics Approvals in 2019: A Systematic Analysis of Patient Experience Data in FDA Drug Approval Packages and Product Labels. [PDF]
Schultz-Knudsen K+4 more
europepmc +1 more source
U.S. Food and Drug Administration Approval: Panitumumab for Epidermal Growth Factor Receptor–Expressing Metastatic Colorectal Carcinoma with Progression Following Fluoropyrimidine-, Oxaliplatin-, and Irinotecan-Containing Chemotherapy Regimens [PDF]
Ruthann M. Giusti+12 more
openalex +1 more source
We generated and characterized clear cell renal cell carcinoma models using the patient‐derived RCC243 cell line—including cell culture, orthotopic, and metastatic tumors—via single‐cell RNA‐sequencing for comparisons between models and patient tumor datasets.
Richard Huang+9 more
wiley +1 more source
Targeted Therapies, Novel Antibodies, and Immunotherapies in Advanced Non-Small Cell Lung Cancer: Clinical Evidence and Drug Approval Patterns. [PDF]
Koban MU+6 more
europepmc +1 more source
Predictors of orphan drug approval in the European Union [PDF]
Harald E. Heemstra+4 more
openalex +1 more source
Liver‐specific knockout of N6‐methyladenosine (m6A) methyltransferase METTL3 significantly accelerated hepatic tumor initiation under various oncogenic challenges, contrary to the previously reported oncogenic role of METTL3 in liver cancer cell lines or xenograft models. Mechanistically, METTL3 deficiency reduced m6A deposition on Manf transcripts and
Bo Cui+15 more
wiley +1 more source