Results 71 to 80 of about 10,049 (144)

Low Incidence of Relapses After Vaccination in Anti‐Aquaporin‐4 Antibody‐Positive NMOSD

Annals of Clinical and Translational Neurology
Patients with neuromyelitis optica spectrum disorder (NMOSD) may experience increased signs and symptoms of their underlying disease when vaccinated against meningococcal disease before receiving complement component 5 inhibitor therapies.
Sean J. Pittock, Jin Nakahara, Becky Parks, Kerstin Allen, Sami Fam   +4 more
doaj   +1 more source

Postmarketing safety evaluation of belimumab: a pharmacovigilance analysis

Lupus Science and Medicine
Objective The present study aimed to provide a comprehensive evaluation of the postmarketing safety of belimumab based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database.Methods Adverse event (AE) reports in the FAERS ...
Huqun Li, Wenlong Xie, Chongshu Wang, Cuilian Guo   +3 more
doaj   +1 more source

A Marginal Structural Modeling Approach with Super Learning for a Study on Oral Bisphosphonate Therapy and Atrial Fibrillation

Journal of Causal Inference, 2013
Purpose: Observational studies designed to investigate the safety of a drug in a postmarketing setting typically aim to examine rare and non-acute adverse effects in a population that is not restricted to particular patient subgroups for which the ...
Neugebauer Romain, Chandra Malini, Paredes Antonio, J. Graham David, McCloskey Carolyn, S. Go Alan   +5 more
doaj   +1 more source

Safety and Efficacy of Vedolizumab for the Patients With Gastrointestinal Acute Graft‐Versus‐Host Disease Refractory to Steroid Treatment After Allogeneic Hematopoietic Stem Cell Transplantation: A Real‐World, Retrospective Multicenter Study (VAST Study)

MedComm, Volume 7, Issue 9, September 2026.
This multicenter, real‐world study with a large sample size (i.e., vedolizumab for aGVHD refractory to steroid treatment, VAST study) was designed to identify the safety and efficacy of vedolizumab treatment in patients with steroid‐refractory gastrointestinal acute graft‐versus‐host disease (SR‐GI‐aGVHD). The overall response rates (ORR) on day 28 and
Leqing Cao, Yi Xia, Song Xue, Jianping Zhang, Jiameng Li, Yuewen Wang, Qi Wen, Ze Tian, Jun Kong, Daoxing Deng, Xiaohui Zhang, Yang Cao, Na Xu, Xiaodong Mo   +13 more
wiley   +1 more source

Facilitating Expedited Drug Approval—the Past, Present, and Future of Clinical Trials for Pediatric Rheumatic Disease

Arthritis Care &Research, Volume 78, Issue 10, Page 1317-1323, October 2026.
Pamela F. Weiss, Hermine I. Brunner
wiley   +1 more source

Real‐World Safety and Effectiveness of Glatiramer Acetate in Patients With Multiple Sclerosis: Final Results of Post‐Marketing Surveillance in Japan

Neurology and Clinical Neuroscience, Volume 14, Issue 5, Page 386-397, September 2026.
ABSTRACT Background Glatiramer acetate is an injectable disease‐modifying therapy indicated for multiple sclerosis (MS). Aim To evaluate the real‐world safety and effectiveness of glatiramer acetate for MS in Japan. Methods A prospective, multicenter, observational, all‐case post‐marketing survey was conducted in Japan between November 2015 and March ...
Masaaki Niino, Eriko Hayashi, Mai Itani, Jun‐ichi Kira   +3 more
wiley   +1 more source

Tobramycin inhalation powder for the treatment of pulmonary infection in patients with cystic fibrosis: a review based on clinical evidence

Therapeutic Advances in Respiratory Disease, 2017
Chronic airway infection with Pseudomonas aeruginosa is a major cause of increased morbidity and mortality in patients with cystic fibrosis (CF). The development and widespread use of nebulized antibacterial therapies, including tobramycin inhalation ...
Kamal Hamed, Laurie Debonnett
doaj   +1 more source

Clinical trials and post-marketing studies of anti-rabies monoclonal antibodies for post-exposure prevention: A review

Биопрепараты: Профилактика, диагностика, лечение
INTRODUCTION. Rabies is an invariably fatal disease having no adequate cure; in some cases it requires administration of rabies immunoglobulin combined with rabies vaccine.
A. Yu. Butirskiy, A. S. Korovkin, A. A. Movsesyants, V. A. Merkulov   +3 more
doaj   +1 more source

Pharmacovigilance analysis of adverse event reports for aliskiren hemifumarate, a first-in-class direct renin inhibitor

Therapeutics and Clinical Risk Management, 2011
Ayad K AliDepartment of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USABackground: The purpose of this study was to examine the postmarketing safety profile of aliskiren hemifumarate, a first-in-class ...
Ali AK
doaj  

US Food and Drug Administration-Mandated Postmarketing Studies for High-risk Cardiovascular Devices Approved 2015-2019.

JAMA Intern Med, 2022
Hidano D, Dhruva SS, Redberg RF.
europepmc   +1 more source