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Drug Safety|February 3, 2022
Sources of Evidence Triggering and Supporting Safety-Related Labeling Changes: A 10-Year Longitudinal Assessment of 22 New Molecular Entities Approved in 2008 by the US Food and Drug AdministrationDavid Croteau, Ellen Pinnow, Eileen Wu, et al.Clinical Pharmacology and Therapeutics|May 31, 2021
The Impact of Variability in Patient Exposure During Premarket Clinical Development on Postmarket Safety OutcomesSanae Cherkaoui, Ellen Pinnow, Ilynn Bulatao, et al.Clinical Pharmacology and Therapeutics|June 20, 2020
Postmarketing Safety-Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002-2014: Similarities and Differences With New Molecular EntitiesIlynn Bulatao, Ellen Pinnow, Brendan Day, et al.Journal of Vascular Surgery|March 6, 2017
Functional status predicts major complications and death after endovascular repair of abdominal aortic aneurysmsDonald G Harris, Ilynn Bulatao, Connor P Oates, et al.Transplantation|February 24, 2012
Proteinuria following sirolimus conversion is associated with deterioration of kidney function in liver transplant recipientsHani M Wadei, Ziad S Zaky, Andrew P Keaveny, et al.Annals of Noninvasive Electrocardiology : the Official Journal of the International Society for Holter and Noninvasive Electrocardiology, Inc|May 9, 2025
Cardiac Adverse Events in Patients Receiving Immune Checkpoint Inhibitors in the Adjuvant Setting: An FDA Pooled AnalysisAsma Dilawari, Mori J Krantz, Ilynn Bulatao, et al.Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|July 17, 2025
FDA Approval Summary: Niraparib Plus Abiraterone Acetate Fixed Dose Combination for BRCA-Mutated Metastatic Castration-Resistant Prostate CancerWilliam F Maguire, Dow-Chung Chi, Sundeep Agrawal, et al.Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|January 14, 2025
FDA Approval Summary: Tovorafenib for Relapsed or Refractory BRAF-Altered Pediatric Low-Grade GliomaSonia Singh, Diana Bradford, Somak Chatterjee, et al.Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology|February 21, 2024
US Food and Drug Administration Approval Summary: Elacestrant for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, ESR1-Mutated Advanced or Metastatic Breast CancerMirat Shah, Hima Lingam, Xin Gao, et al.Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|February 1, 2022
FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as Single Agents for First-Line Treatment of Advanced/Metastatic PD-L1-High NSCLCOladimeji Akinboro, Erin Larkins, Lee H Pai-Scherf, et al.Pageof 2