Results 11 to 20 of about 25,471 (263)

Postmarketing safety of orphan drugs: a longitudinal analysis of the US Food and Drug Administration database between 1999 and 2018

Orphanet Journal of Rare Diseases, 2022
Background Information about the specific regulatory environment of orphan drugs is scarce and inconsistent. Uncertainties surrounding the postmarketing long-term safety of orphan drugs remain. This study aimed to evaluate the labelling changes of orphan
Min Fan, Adrienne Y. L. Chan, Vincent K. C. Yan, Xinning Tong, Lauren K. W. Lau, Eric Y. F. Wan, Eliza Y. T. Tam, Patrick Ip, Terry Y. Lum, Ian C. K. Wong, X. Li   +10 more
doaj   +2 more sources

Safety of Brexanolone in Adults with Postpartum Depression: Postmarketing Surveillance Data

Drugs - Real World Outcomes, 2023
Background Brexanolone is currently the only medication approved by the US FDA for the treatment of postpartum depression (PPD) in patients ≥15 years. Brexanolone is available commercially only through a restricted program (ZULRESSO® Risk Evaluation and ...
Svetlana Garafola, Elizabeth Shiferaw, Vikram Dev   +2 more
doaj   +2 more sources

Overview of the Premarketing and Postmarketing Requirements for Drugs Granted Japanese Conditional Marketing Approval

Clinical and Translational Science, 2021
For drugs that are intended to fill unmet medical needs, such as the treatment of rare diseases or a subtype of cancer, it can take a long time to conduct confirmatory clinical trials due to limited patient availability.
Shunsuke Matsushita, Keisuke Tachibana, Tetsuya Kusakabe, Ryuichi Hirayama, Yasuo Tsutsumi, Masuo Kondoh   +5 more
doaj   +2 more sources

Pregnancy Outcomes in Patients Treated with Upadacitinib: Analysis of Data from Clinical Trials and Postmarketing Reports. [PDF]

Drug Saf
Background and Objective Upadacitinib is indicated for diseases affecting persons of childbearing potential including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, Crohn’s disease, and ulcerative colitis; however,
Mahadevan U, Levy G, Gensler L, Ali M, Lacerda AP, Wegrzyn L, Palac H, Bhutani-Jacques T, Long M, Clowse MEB, Kimball AB, Chambers C, Scialli AR.   +12 more
europepmc   +2 more sources

Adverse events with risankizumab in the real world: postmarketing pharmacovigilance assessment of the FDA adverse event reporting system

Frontiers in Immunology, 2023
Background Risankizumab, a humanized IgG1 monoclonal antibody that selectively inhibits IL-23, is currently approved for the treatment of moderate-to-severe plaque psoriasis and Crohn’s disease.
Yamin Shu, J. Chen, Yiling Ding, Qilin Zhang   +3 more
semanticscholar   +1 more source

Clinical Trial and Postmarketing Safety of Onasemnogene Abeparvovec Therapy

Drug Safety, 2021
This is the first description of safety data for intravenous onasemnogene abeparvovec, the only approved systemically administered gene-replacement therapy for spinal muscular atrophy.
J. Day, J. Mendell, E. Mercuri, R. Finkel, K. Strauss, A. Kleyn, S. Tauscher‐Wisniewski, F. Tukov, S. Reyna, D. Chand   +9 more
semanticscholar   +1 more source

Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports

Annals of the Rheumatic Diseases, 2022
Objective Describe available data on birth defects and pregnancy loss in women with systemic lupus erythematosus (SLE) exposed to belimumab. Methods Data collected from belimumab clinical trials, the Belimumab Pregnancy Registry (BPR), and postmarketing ...
M. Petri, H. Landy, M. Clowse, K. Gemzoe, M. Khamashta, M. Kurtinecz, R. Levy, Andrew Liu, Rebecca Marino, P. Meizlik, J. Pimenta, Kelsey M. Sumner, H. Tilson, Mary Beth Connolly, Keele E Wurst, J. Harris, H. Quasny, Patricia Juliao, D. Roth   +18 more
semanticscholar   +1 more source

A review of pregnancy and lactation postmarketing studies required by the FDA

Pharmacoepidemiology and Drug Safety, 2022
Since pregnant and lactating women have historically been excluded from drug development trials, safety studies need to be conducted postapproval. This study evaluated FDA's Post Marketing Requirements for pregnancy and lactation studies from 2007 to ...
Jason Krastein, L. Sahin, L. Yao
semanticscholar   +1 more source

Risk of hypertension in erenumab‐treated patients with migraine: Analyses of clinical trial and postmarketing data

Headache, 2021
To assess the risk of hypertension in patients with migraine who received erenumab in clinical trials and in the postmarketing setting.
D. Dodick, S. Tepper, J. Ailani, N. Pannacciulli, Marco S. Navetta, B. Loop, Feng Zhang, A. Khodavirdi, Allison Mann, Ahmad M. Abdrabboh, Jawed Kalim   +10 more
semanticscholar   +1 more source

Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics

JAMA Network Open, 2021
This cross-sectional study investigates demographic data reporting and demographic representation by sex, age, and race/ethnicity in premarketing and postmarketing studies of novel cancer therapeutics.
Tanvee Varma, J. Wallach, Jennifer E. Miller, Dominic Schnabel, Joshua J. Skydel, A. Zhang, M. Dinan, J. Ross, C. Gross   +8 more
semanticscholar   +1 more source