Works matching DE "UNITED States. Food %26 Drug Administration"

Results: 5000

Novel immune checkpoint blocker approved for the treatment of advanced melanoma.

Published in:

2014

By:

Galluzzi, Lorenzo;
Kroemer, Guido;
Eggermont, Alexander

Publication type:

Editorial

Trial Watch.

Published in:

OncoImmunology, 2014, v. 3, n. 6, p. N.PAG, doi. 10.4161/onci.29179

By:

Aranda, Fernando;
Vacchelli, Erika;
Obrist, Florine;
Eggermont, Alexander;
Galon, Jérôme;
Sautès-Fridman, Catherine;
Cremer, Isabelle;
Henrik ter Meulen, Jan;
Zitvogel, Laurence;
Kroemer, Guido;
Galluzzi, Lorenzo

Publication type:

Article

Novel insights into the mechanism of action of lenalidomide.

Published in:

OncoImmunology, 2014, v. 3, n. 2, p. N.PAG, doi. 10.4161/onci.28386

By:

Semeraro, Michaela;
Galluzzi, Lorenzo

Publication type:

Article

Trial Watch.

Published in:

OncoImmunology, 2014, v. 3, n. 2, p. N.PAG, doi. 10.4161/onci.27297

By:

Aranda, Fernando;
Vacchelli, Erika;
Eggermont, Alexander;
Galon, Jérôme;
Fridman, Wolf Hervé;
Zitvogel, Laurence;
Kroemer, Guido;
Galluzzi, Lorenzo

Publication type:

Article

Novel multifunctional antibody approved for the treatment of breast cancer.

Published in:

2013

By:

Mavilio, Domenico;
Galluzzi, Lorenzo;
Lugli, Enrico

Publication type:

Editorial

Trial watch Monoclonal antibodies in cancer therapy.

Published in:

OncoImmunology, 2013, v. 2, n. 1, p. e22789-1, doi. 10.4161/onci.22789

By:

Vacchelli, Erika;
Eggermont, Alexander;
Galon, Jérôme;
Sautès-Fridman, Catherine;
Zitvogel, Laurence;
Kroemer, Guido;
Galluzzi, Lorenzo

Publication type:

Article

Evaluating the clinical benefit of pembrolizumab as a first-line agent in advanced solid tumors: A comprehensive review.

Published in:

Journal of Oncology Pharmacy Practice, 2025, v. 31, n. 4, p. 616, doi. 10.1177/10781552241252100

By:

Mohamed, Amna;
Salman, Bushra;
Shaikh, Asim Jamal

Publication type:

Article

Proteometabolomics of bladder cancer: Current and future prospects.

Published in:

Cancer Biomarkers, 2015, v. 15, n. 4, p. 339, doi. 10.3233/CBM-150479

By:

Bansal, Navneeta;
Gupta, Ashish;
Sankhwar, Satya Narain

Publication type:

Article

Overview of precancer and goals of the meeting.

Published in:

Cancer Biomarkers, 2007, v. 3, n. 1, p. 35

By:

Kelloff, Gary J.

Publication type:

Article

Sunitinib alone or in combination with chemotherapy for the treatment of advanced breast cancer: A systematic review and meta-analysis.

Published in:

Breast Disease, 2016, v. 36, n. 2/3, p. 91, doi. 10.3233/BD-160218

By:

Elgebaly, Ahmed;
Menshawy, Ahmed;
El Ashal, Gehad;
Osama, Omnya;
Ghanem, Esraa;
Omar, Ahmed;
Negida, Ahmed

Publication type:

Article

Surgically placed wound catheters (SPWC) and local anaesthetic infusion in breast surgery: Efficacy and safety analysis.

Published in:

Breast Disease, 2012, v. 33, n. 1, p. 1

By:

Raghavendra, G.K.G.;
Sreenivasa, R.H.;
Ashok, K.;
Chitsabesan, P.;
McLean, N.R.;
Youssef, M.;
Piper, M.;
Carr, M.

Publication type:

Article

FDA Says Fresenius Kabi Is Recalling Incorrectly Assembled Large-Volume Pump Blood Product Administration Sets.

Published in:: ONS Voice, 2025, p. N.PAG
Publication type:: Article

FDA Says Zyno Medical Is Removing Certain Z-800 Series Infusion Pumps for a Software Issue.

Published in:: ONS Voice, 2025, p. N.PAG
Publication type:: Article

Mini review: The FDA-approved prescription drugs that target the MAPK signaling pathway in women with breast cancer.

Published in:

Breast Disease, 2021, v. 40, n. 2, p. 51, doi. 10.3233/BD-201063

By:

Khojasteh Poor, Fatemeh;
Keivan, Mona;
Ramazii, Mohammad;
Ghaedrahmati, Farhoodeh;
Anbiyaiee, Amir;
Panahandeh, Samira;
Khoshnam, Seyed Esmaeil;
Farzaneh, Maryam

Publication type:

Article

Trial watch: Chemotherapy with immunogenic cell death inducers.

Published in:

OncoImmunology, 2012, v. 1, n. 2, p. 179, doi. 10.4161/onci.1.2.19026

By:

Vacchelli, Erika;
Galluzzi, Lorenzo;
Fridman, Wolf Hervé;
Galon, Jerome;
Sautès-Fridman, Catherine;
Tartour, Eric;
Zitvogel, Laurence;
Kroemer, Guido

Publication type:

Article

Efficacy of Istradefylline, an Adenosine A<sub>2A</sub> Receptor Antagonist, as Adjunctive Therapy to Levodopa in Parkinson's Disease: A Pooled Analysis of 8 Phase 2b/3 Trials.

Published in:

Journal of Parkinson's Disease, 2021, v. 11, n. 4, p. 1663, doi. 10.3233/JPD-212672

By:

Hauser, Robert A.;
Hattori, Nobutaka;
Fernandez, Hubert;
Isaacson, Stuart H.;
Mochizuki, Hideki;
Rascol, Olivier;
Stocchi, Fabrizio;
Li, June;
Mori, Akihisa;
Nakajima, Yu;
Ristuccia, Robert;
LeWitt, Peter

Publication type:

Article

Parkinson's Disease Drug Development Since 1999: A Story of Repurposing and Relative Success.

Published in:

Journal of Parkinson's Disease, 2021, v. 11, n. 2, p. 421, doi. 10.3233/JPD-202184

By:

Boucherie, Deirdre M.;
Duarte, Gonçalo S.;
Machado, Tiago;
Faustino, Patrícia R.;
Sampaio, Cristina;
Rascol, Olivier;
Ferreira, Joaquim J.

Publication type:

Article

Digital Health Technology to Measure Drug Efficacy in Clinical Trials for Parkinson's Disease: A Regulatory Perspective.

Published in:

Journal of Parkinson's Disease, 2021, v. 11, p. S111, doi. 10.3233/JPD-202416

By:

Sacks, Leonard;
Kunkoski, Elizabeth

Publication type:

Article

Patient-Centered Approach in IBS-C Management.

Published in:

Gastroenterology & Hepatology, 2025, v. 21, p. 362

By:

Kongara, Kavita

Publication type:

Article

Beyond the Scope: The Promise and Limitations of Blood-Based Colorectal Cancer Screening.

Published in:

Gastroenterology & Hepatology, 2025, v. 21, p. 397

By:

Dominitz, Jason A.

Publication type:

Article

The Relative Reinforcing Value of Menthol Among Young Adult Cigarette Smokers: Results From a Behavioral Choice Task Open Access.

Published in:

Nicotine & Tobacco Research, 2025, v. 27, n. 7, p. 1177, doi. 10.1093/ntr/ntae186

By:

Cohn, Amy M;
Elmasry, Hoda;
Ashare, Rebecca;
Pickworth, Wallace;
Murphy, James G;
Villanti, Andrea C;
Hedeker, Donald;
Dunn, Delaney;
Wyatt, Riley;
Niznik, Taylor;
Margaritis, Whitney D;
Smith, Michael A;
Ehlke, Sarah J;
Audrain-McGovern, Janet

Publication type:

Article

Assessment of the Risks of Transgenic Fluorescent Ornamental Fishes to the United States Using the Fish Invasiveness Screening Kit (FISK).

Published in:

Transactions of the American Fisheries Society, 2014, v. 143, n. 3, p. 817, doi. 10.1080/00028487.2014.880741

By:

Hill, Jeffrey E.;
Lawson, Larry L.;
Hardin, Scott

Publication type:

Article

Characterization of the nutrient profile of processed red raspberries for use in nutrition labeling and promoting healthy food choices.

Published in:

Nutrition & Healthy Aging, 2019, v. 5, n. 3, p. 225, doi. 10.3233/NHA-190072

By:

Zhang, Xuhuiqun;
Ahuja, Jaspreet K.C.;
Burton-Freeman, Britt M.

Publication type:

Article

Artri King induced Cushing syndrome in an 82-year-old man.

Published in:

Dermatology Online Journal, 2025, v. 31, n. 3, p. 1, doi. 10.5070/D331365365

By:

Suyoung Choi;
Christopher Youn;
Vivian Yang;
Christina Bax;
Gordon Bae

Publication type:

Article

Ethical Debate Continues Over Access to Investigational Cell- and Gene-Based Interventions.

Published in:: Medical Ethics Advisor, 2025, v. 41, n. 7, p. 1
Publication type:: Article

Oncology Drug Reference Sheet: Datopotamab Deruxtecan-Dlnk.

Published in:: ONS Voice, 2025, p. N.PAG
Publication type:: Article

Considering Relative Rurality in Tobacco Regulatory Science.

Published in:

Nicotine & Tobacco Research, 2025, v. 27, n. 6, p. 1147, doi. 10.1093/ntr/ntae303

By:

Rayens, Mary Kay;
Kingsolver, Ann E;
Christian, W Jay;
Hahn, Ellen J;
Waters, Teresa M;
Rose, Shyanika W;
Koffarnus, Mikhail N;
Himelhoch, Seth;
(AppalTRUST), Appalachian Tobacco Regulatory Science Team

Publication type:

Article

Effects of E-Cigarette Warning Labels About Mental Health Consequences of Nicotine Addiction Among Young Adults in the USA: Results From a Randomized Controlled Experiment.

Published in:

Nicotine & Tobacco Research, 2025, v. 27, n. 6, p. 1006, doi. 10.1093/ntr/ntae298

By:

Marynak, Kristy L;
Cohen, Joanna E;
Thrul, Johannes;
Kennedy, Ryan D;
Limaye, Rupali;
Moran, Meghan B

Publication type:

Article

Qualitative Examination of US and Israeli Adults' Perceptions of IQOS Advertising Messages: Modified Exposure and Risk Statements, US FDA Endorsement, and Health Warnings.

Published in:

Nicotine & Tobacco Research, 2025, v. 27, n. 6, p. 1083, doi. 10.1093/ntr/ntae266

By:

Berg, Carla J;
Levine, Hagai;
LoParco, Cassidy R;
Cui, Yuxian;
Khayat, Amal;
Duan, Zongshuan;
Abroms, Lorien C;
Wang, Yan;
Bar-Zeev, Yael

Publication type:

Article

Regulatory framework and challenges for live biotherapeutic products in Taiwan.

Published in:

Journal of Food & Drug Analysis, 2025, v. 33, n. 2, p. 97, doi. 10.38212/2224-6614.3540

By:

Shirley Pan;
Jia-Chuan Hsu;
Kuo-Teng Hung;
Ching-Jung Ho

Publication type:

Article

HHS, FDA Initiate Comprehensive Review of Nutrients in Infant Formula.

Published in:: Neonatology Today, 2025, v. 20, n. 5, p. 162
Publication type:: Article

RSV hospitalizations for youngest babies cut in half after immunizations become available.

Published in:

Neonatology Today, 2025, v. 20, n. 5, p. 159

By:

Jenco, Melissa

Publication type:

Article

Tremfya's FDA Win as Fully Subcutaneous Option for Crohn's May Pave Way to Eclipse Stelara.

Published in:

Healio Gastroenterology, 2025, v. 11, n. 5, p. 15

By:

Stott, Robert

Publication type:

Article

Anti-IL-23s Reporting for Duty: A New Line of Defense in Crohn's, UC.

Published in:

2025

By:

Loftus Jr., Edward V.

Publication type:

Editorial

FDA Approves Taletrectinib for ROS1-Positive Non-Small Cell Lung Cancer.

Published in:: ONS Voice, 2025, p. N.PAG
Publication type:: Article

Certification Marks for Supporting Generic Drug Quality.

Published in:

Journal of Law, Medicine & Ethics, 2025, v. 53, n. 1, p. 168, doi. 10.1017/jme.2025.56

By:

Lindgren, Lars;
Kesselheim, Aaron S.;
Tu, S. Sean

Publication type:

Article

Patent Thickets and Product Hops: Challenges and Opportunities for Legislative Reform.

Published in:

Journal of Law, Medicine & Ethics, 2025, v. 53, n. 1, p. 158, doi. 10.1017/jme.2025.54

By:

Feldman, William B.

Publication type:

Article

FDA Advisory Committee Review of Supplemental Indications and Reasons for Non-Approval, 2008-2022.

Published in:

Journal of Law, Medicine & Ethics, 2025, v. 53, n. 1, p. 137, doi. 10.1017/jme.2025.53

By:

Zhang, Audrey D.;
Chaudhry, Nikhil;
Ramachandran, Reshma;
Ross, Joseph S.;
Schwartz, Jason L.

Publication type:

Article

What Can We Learn from Patient Input at FDA Advisory Committee Meetings?

Published in:

Journal of Law, Medicine & Ethics, 2025, v. 53, n. 1, p. 145, doi. 10.1017/jme.2025.52

By:

Rand, Leah Z;
Eisenkraft Klein, Daniel

Publication type:

Article

Suzetrigine.

Published in:: American Journal of Health-System Pharmacy, 2025, v. 82, n. 12, p. 635, doi. 10.1093/ajhp/zxaf054
Publication type:: Article

Moving forward from Cockcroft-Gault creatinine clearance to race-free estimated glomerular filtration rate to improve medication-related decision-making in adults across healthcare settings: A consensus of the National Kidney Foundation Workgroup for Implementation of Race-Free eGFR-Based Medication-Related Decisions Free

Published in:

American Journal of Health-System Pharmacy, 2025, v. 82, n. 12, p. 644, doi. 10.1093/ajhp/zxae317

By:

Peter, Wendy L St.;
Bzowyckyj, Andrew S;
Anderson-Haag, Tracy;
Awdishu, Linda;
Blackman, Michael;
Bland, Andrew;
Chan, Ethan;
Chmielewski, Christine;
Delgado, Cynthia;
Eyler, Rachel;
Foster, Charles;
Hudson, Joanna;
Kane-Gill, Sandra L;
Kliethermes, Mary Ann;
Le, Tuan;
Madabushi, Rajanikanth;
Martin, Brianna;
Miller, W Greg;
Neumiller, Joshua J;
Philbrick, Ann M

Publication type:

Article

Real‐World Evidence in New Drug and Biologics License Application Approvals During Fiscal Years 2020–2022.

Published in:

Clinical Pharmacology & Therapeutics, 2025, v. 118, n. 1, p. 85, doi. 10.1002/cpt.3688

By:

Innes, Gabriel K.;
Smith, Kimberly A.;
Kuzucan, Aida;
Li, Jie;
Rivera, Donna;
Panagiotou, Orestis A.;
Concato, John

Publication type:

Article

Participants in the FDA's Biomarker Qualification Program.

Published in:

Clinical Pharmacology & Therapeutics, 2025, v. 118, n. 1, p. 80, doi. 10.1002/cpt.3661

By:

Shahzad, Mahnum;
Stern, Ariel D.

Publication type:

Article

The need to transition from paper to electronic instructions for use for diabetes devices.

Published in:

NPJ Digital Medicine, 2025, v. 8, n. 1, p. 1, doi. 10.1038/s41746-025-01720-0

By:

Ho, Cindy N.;
Ayers, Alessandra T.;
Heinemann, Lutz;
Klonoff, David C.

Publication type:

Article

Approval Disparities for New Drugs in the US and Japan.

Published in:

JAMA Network Open, 2025, v. 8, n. 6, p. e2513640, doi. 10.1001/jamanetworkopen.2025.13640

By:

Kasahara, Shingo;
Wakutsu, Naohiko;
Nakamura, Hiroshi

Publication type:

Article

Biological Network Analysis of Genes and Non-coding RNAs in Polycystic Ovary Syndrome.

Published in:

Cyprus Journal of Medical Sciences, 2025, v. 10, p. 1, doi. 10.4274/cjms.2025.2024-131

By:

Hasanzadeh, Bita Ostad;
Hasanzadeh, Parham Ostad;
Tulay, Pınar

Publication type:

Article

The laboratory-developed test rule is vacated: But laboratories should still prepare for the future.

Published in:

Medical Laboratory Observer (MLO), 2025, v. 57, n. 4, p. 14

By:

Bickley, Tim

Publication type:

Article

Efficient protoplast isolation and transient gene expression in dahlia (Dahlia sp.).

Published in:

Plant Biotechnology Reports, 2025, v. 19, n. 3, p. 243, doi. 10.1007/s11816-025-00970-4

By:

Zhou, Jing;
Yang, Dong;
Tian, YangBo;
Tian, Zhen;
Duan, Qing;
Ahmed, Mohamed A. A.;
Wang, LiHua;
Wu, XueWei

Publication type:

Article

Suitability petitions, its evaluation process and US FDA's response to the suitability petitions: Insights from the first half of GDUFA III.

Published in:

Journal of Generic Medicines, 2025, v. 21, n. 2, p. 83, doi. 10.1177/17411343251345630

By:

Chokshi, Nirav;
Modi, Bhaumik;
Raval, Grishma

Publication type:

Article

How small, high-complexity testing labs can adapt to FDA LDT regulatory shifts.

Published in:

Medical Laboratory Observer (MLO), 2025, v. 57, n. 2, p. 20

By:

Dotson, Dominique;
Mullen, Cathryn;
Quash, Kellie

Publication type:

Article