Results 171 to 180 of about 5,545,002 (288)

Minimal Residual Disease as an Early Endpoint for Accelerated Drug Approval in Myeloma: A Roadmap. [PDF]

Blood Cancer Discov
Landgren O, Devlin SM.
europepmc   +1 more source

First Tissue-Agnostic Drug Approval Issued.

Cancer Discovery, 2017

semanticscholar   +1 more source

Accelerated Approval of Cancer Drugs: Improved Access to Therapeutic Breakthroughs or Early Release of Unsafe and Ineffective Drugs? [PDF]

, 2009
Elizabeth Richey, Erica Lyons, Jonathan R. Nebeker, Veena Shankaran, June M. McKoy, Thanh Ha Luu, Narissa J. Nonzee, Steven Trifilio, Oliver Sartor, Al B. Benson, Kenneth R. Carson, Beatrice J. Edwards, Douglas Gilchrist-Scott, Timothy M. Kuzel, Dennis W. Raisch, Martin S. Tallman, Dennis P. West, Steven Hirschfeld, Antonio J Grillo-López, Charles L. Bennett   +19 more
openalex   +1 more source

Critical insights into the evolving drug-approval process in China. [PDF]

Cancer
Nikanjam M, Kurzrock R.
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]

BMC Cancer, 2022
Sharp J, Prasad V.
europepmc   +1 more source

Minimum requirements for approval of a drug in status epilepticus [PDF]

, 2009
Michel Baulac, Vincent Navarro
openalex   +1 more source

Targeted Therapies, Novel Antibodies, and Immunotherapies in Advanced Non-Small Cell Lung Cancer: Clinical Evidence and Drug Approval Patterns. [PDF]

Clin Cancer Res
Koban MU, Hartmann M, Amexis G, Franco P, Huggins L, Shah I, Karachaliou N.   +6 more
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]

Ther Innov Regul Sci, 2021
Schultz-Knudsen K, Sabaliauskaite U, Hellsten J, Lassen AB, Morant AV.   +4 more
europepmc   +1 more source

U.S. Food and Drug Administration Approval: Ofatumumab for the Treatment of Patients with Chronic Lymphocytic Leukemia Refractory to Fludarabine and Alemtuzumab [PDF]

, 2010
Steven J. Lemery, Jenny Zhang, Mark D. Rothmann, Jun Yang, Justin Earp, Hong Zhao, Andrew McDougal, Anne M. Pilaro, Raymond Chiang, Joseph E. Gootenberg, Patricia Keegan, Richard Pazdur   +11 more
openalex   +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]

Cancer
Boyiadzis M, Wei AH, Paiva B, Freeman SD, Kaspers G, Chyla B, Hersey S, Patel R, Maloney B, Blanchet Zumofen MH, Van Hoef M, Wulff B, Obourn V, Patel S, Lopes de Menezes D, Shi Q, Bengoudifa BR, Dimier N, Prior TJ, Roboz GJ, Prebet T.   +20 more
europepmc   +1 more source