Works about DRUG approval

Results: 5000

The Clinical and Economic Value of Follow-on Biologics: Biosimilars, Biobetters, and Bioparallels.

Published in:

British Journal of Hospital Medicine (17508460), 2025, v. 86, n. 6, p. 1, doi. 10.12968/hmed.2024.1036

By:

Abraham, Ivo;
Beddor, Ansam Nail;
MacDonald, Karen Michelle

Publication type:

Article

Vonoprazan: A Review in Erosive Esophagitis and Non-Erosive Gastro-Esophageal Reflux Disease.

Published in:

Drugs, 2025, v. 85, n. 7, p. 945, doi. 10.1007/s40265-025-02193-x

By:

Fung, Simon

Publication type:

Article

Vimseltinib: First Approval.

Published in:

Drugs, 2025, v. 85, n. 7, p. 985, doi. 10.1007/s40265-025-02191-z

By:

Lee, Arnold

Publication type:

Article

Mirdametinib: First Approval.

Published in:

Drugs, 2025, v. 85, n. 7, p. 977, doi. 10.1007/s40265-025-02190-0

By:

Hoy, Sheridan M.

Publication type:

Article

Catumaxomab: First Approval.

Published in:

Drugs, 2025, v. 85, n. 7, p. 957, doi. 10.1007/s40265-025-02187-9

By:

Syed, Yahiya Y.

Publication type:

Article

Datopotamab Deruxtecan: First Approval.

Published in:

Drugs, 2025, v. 85, n. 7, p. 965, doi. 10.1007/s40265-025-02185-x

By:

Blair, Hannah A.

Publication type:

Article

Repurposing FDA‐Approved Drugs to Target MTH1 for Anticancer Therapeutics.

Published in:

Journal of Molecular Recognition, 2025, v. 38, n. 3, p. 1, doi. 10.1002/jmr.70005

By:

Taiyab, Aaliya;
Sulaimani, Md Nayab;
Rathi, Aanchal;
Khan, Fazlurrahman;
Hussain, Afzal;
Alajmi, Mohamed F.;
Hassan, Md. Imtaiyaz

Publication type:

Article

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

Published in:

2014

By:

Galluzzi, Lorenzo;
Kroemer, Guido;
Eggermont, Alexander

Publication type:

Editorial

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

Novel multifunctional antibody approved for the treatment of breast cancer.

Published in:

2013

By:

Mavilio, Domenico;
Galluzzi, Lorenzo;
Lugli, Enrico

Publication type:

Editorial

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

A Comprehensive Overview of US-FDA-Approved Anticancer Drugs and Biologics in 2023: An Observational Study.

Published in:

Journal of Pharmacy & Bioallied Sciences, 2025, v. 17, n. 1, p. 27, doi. 10.4103/jpbs.jpbs_730_25

By:

Shukla, Ajay Kumar;
Misra, Saurav

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

Issues Regarding the Use of Sedatives in Fisheries and the Need for Immediate‐Release Options.

Published in:

Transactions of the American Fisheries Society, 2013, v. 142, n. 1, p. 156, doi. 10.1080/00028487.2012.732651

By:

Trushenski, J. T.;
Bowker, J. D.;
Cooke, S. J.;
Erdahl, D.;
Bell, T.;
MacMillan, J. R.;
Yanong, R. P.;
Hill, J. E.;
Fabrizio, M. C.;
Garvey, J. E.;
Sharon, S.

Publication type:

Article

Type 1 Diabetes TrialNet: Leading the Charge in Disease Prediction, Prevention, and Immunotherapeutic Mechanistic Understanding.

Published in:

Diabetes Care, 2025, v. 48, n. 7, p. 1112, doi. 10.2337/dc24-2908

By:

Jacobsen, Laura M.;
Felton, Jamie L.;
Nathan, Brandon M.;
Speake, Cate;
Krischer, Jeffrey;
Herold, Kevan C.

Publication type:

Article

FDA Approves Tafasitamab-Cxix for Relapsed or Refractory Follicular Lymphoma.

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

Oncology Drug Reference Sheet: Datopotamab Deruxtecan-Dlnk.

Published in:: ONS Voice, 2025, p. N.PAG
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

3 Things You Should Know About Targeting NRG1 and Rare Drivers in Pancreatic Cancer.

Published in:

Oncology (08909091), 2025, v. 39, n. 5, p. 204

By:

Chiorean, E. Gabriela;
Ahn, Daniel H.;
Weinberg, Benjamin A.

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

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

Seminare und Tagungen.

Published in:: Zeitschrift für Stoffrecht, 2025, v. 22, n. 2, p. I
Publication type:: Article

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

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

The cost of emulated target trials: Is real‐world data cheaper than randomized studies?

Published in:

European Journal of Clinical Investigation, 2025, v. 55, n. 7, p. 1, doi. 10.1111/eci.70035

By:

Barosa, Mariana;
Prasad, Vinay

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

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

Clinical Benefit, Trials, and Regulatory Approval of Oncology Indications Under Multiple Expedited Programs for Drug Marketing in China, 2018–2024.

Published in:

Clinical Pharmacology & Therapeutics, 2025, v. 118, n. 1, p. 195, doi. 10.1002/cpt.3676

By:

Zhang, Jie;
Yang, Li

Publication type:

Article

Signal Alert: Startup Seeks Community Funders for AAV Immuno-Gene Therapy.

Published in:

GEN Biotechnology, 2025, v. 4, n. 3, p. 104, doi. 10.1089/genbio.2025.0021

By:

Philippidis, Alex

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 Journal of Generic Medicines – Editorial June 2025.

Published in:

2025

By:

Tempest, Brian

Publication type:

Editorial

Revisiting Patent Linkage.

Published in:

Texas Intellectual Property Law Journal, 2025, v. 33, n. 3, p. 291

By:

Thomas, John R.

Publication type:

Article

p16/ki‐67 dual stain triage of individuals positive for HPV to detect cervical precancerous lesions.

Published in:

International Journal of Cancer, 2025, v. 156, n. 12, p. 2257, doi. 10.1002/ijc.35353

By:

Harper, Diane M.;
Paczos, Tamera;
Ridder, Ruediger;
Huh, Warner K.

Publication type:

Article

How many people in the US are eligible for and respond to checkpoint inhibitors: An empirical analysis.

Published in:

International Journal of Cancer, 2025, v. 156, n. 12, p. 2352, doi. 10.1002/ijc.35347

By:

Haslam, Alyson;
Olivier, Timothée;
Prasad, Vinay

Publication type:

Article

Fluorescence-Guided Surgery for Gliomas: Past, Present, and Future.

Published in:

Cancers, 2025, v. 17, n. 11, p. 1837, doi. 10.3390/cancers17111837

By:

Rodriguez, Benjamin;
Brown, Cole S.;
Colan, Jhair Alejandro;
Zhang, Jack Yin;
Huq, Sakibul;
Rivera, Daniel;
Young, Tirone;
Williams, Tyree;
Subramaniam, Varun;
Hadjipanayis, Constantinos

Publication type:

Article

Belzutifan's role in the treatment landscape of clear cell renal cell carcinoma.

Published in:

Pharmacotherapy, 2025, v. 45, n. 6, p. 356, doi. 10.1002/phar.70023

By:

Chen, Adrienne H.;
Grana, Allison K.

Publication type:

Article

Transforming Oncology: Innovation, Agility, and the Future of Pharma.

Published in:: Oncology Practice Management, 2025, v. 15, n. 6, p. 17
Publication type:: Article

Issues in Clinical Trial Design—Lessons From the FDA's Rejection of MDMA.

Published in:

2025

By:

Wilkinson, Samuel T.;
Sanacora, Gerard

Publication type:

Opinion

Introduction to Part II of the Special Issue Honoring Dr. Robert T. O'Neill's Contribution to Regulatory Statistical Science.

Published in:

Statistics in Biopharmaceutical Research, 2013, v. 5, n. 4, p. 280, doi. 10.1080/19466315.2013.852874

By:

Anello, Chuck

Publication type:

Article

Contributions of Robert T. O'Neill to the Evolution of Regulatory Statistical Science.

Published in:

Statistics in Biopharmaceutical Research, 2013, v. 5, n. 3, p. 262, doi. 10.1080/19466315.2013.818817

By:

Anello, Charles;
Junod, Suzanne

Publication type:

Article

Introduction to the Special Issue Honoring Dr. Robert T. O'Neill's Contribution to Regulatory Statistical Science.

Published in:

Statistics in Biopharmaceutical Research, 2013, v. 5, n. 3, p. 156, doi. 10.1080/19466315.2013.818815

By:

Anello, Chuck

Publication type:

Article

Being Efficient About Efficacy Estimation.

Published in:

Statistics in Biopharmaceutical Research, 2013, v. 5, n. 3, p. 204, doi. 10.1080/19466315.2012.754726

By:

Senn, Stephen

Publication type:

Article

Patient Preference on Age-Related Macular Degeneration Treatment: A Systematic Review.

Published in:

Patient Preference & Adherence, 2025, v. 19, p. 1639, doi. 10.2147/PPA.S513165

By:

Kawasaki, Atsuko;
Yuki, Miho;
Nakagawa, Shizuka;
Iwasaki, Keisuke;
Ochi, Haruka;
Sugitani, Yasuo

Publication type:

Article

From the Editor. Tardive Dyskinesia: Treat Functional Impairment, Not the AIMS Score.

Published in:

Psychiatric Times, 2025, v. 42, n. 6, p. 4

By:

Miller, John J.

Publication type:

Article

FDA Approves Darolutamide for Metastatic Castration-Sensitive Prostate Cancer.

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

Toxicity of CAR T-Cell Therapy for Multiple Myeloma.

Published in:

Acta Haematologica, 2025, v. 148, n. 3, p. 300, doi. 10.1159/000539134

By:

Afrough, Aimaz;
Abraham, Pearl Rajan;
Turer, Laura;
Kaur, Gurbakhash;
Sannareddy, Aishwarya;
Hansen, Doris K.;
Anderson Jr., Larry D.

Publication type:

Article

Quick Reference Drug Chart.

Published in:: Journal of Psychosocial Nursing & Mental Health Services, 2025, v. 63, n. 6, p. 5, doi. 10.3928/02793695-20250507-79
Publication type:: Article

Clozapine in the Spotlight: Understanding the Recent Clozapine REMS Changes and a Research Update for 2025.

Published in:

Issues in Mental Health Nursing, 2025, v. 46, n. 6, p. 633, doi. 10.1080/01612840.2025.2503132

By:

Mills, Jeremy;
Long, Anna Catherine

Publication type:

Article

Twenty-one-year report from the Danish Health Authority Expert Advisory Panel for review of treatment of 10 000 cancer patients.

Published in:

Oncologist, 2025, v. 30, n. 5, p. 1, doi. 10.1093/oncolo/oyaf059

By:

Ladekarl, Morten;
Mørk, Mette Louise;
Albertsen, Emma Skotte;
Nielsen, Dorte;
Lassen, Ulrik;
Mau-Sørensen, Morten;
Nielsen, Claus Malta;
Jakobsen, Anders;
von der Maase, Hans

Publication type:

Article

Interdisciplinary Swiss Consensus Recommendations on Management of Advanced Prostate Cancer.

Published in:

Praxis (16618157), 2025, v. 114, n. 5, p. 172

By:

Templeton, Arnoud J.;
Achard, Vérane;
Akhoundova, Dilara;
Burger, Irene A.;
Eberli, Daniel;
Engeler, Daniel;
Erdmann, Andreas;
Fischer, Stefanie;
Grobholz, Rainer;
Lorch, Anja;
Niederberger, Philip;
Omlin, Aurelius;
Papachristofilou, Alexandros;
Prause, Lukas;
Reichel, Katharina;
Rentsch, Cyrill A.;
Shelan, Mohamed;
Stenner, Frank;
Tsantoulis, Petros;
Vogl, Ursula

Publication type:

Article