Works matching DE "DRUG approval"

Results: 5000

Pivotal trial characteristics and types of endpoints used to support Food and Drug Administration rare disease drug approvals between 2013 and 2022.

Published in:

Clinical Trials, 2025, v. 22, n. 3, p. 352, doi. 10.1177/17407745241309318

By:

Hong, Kyungwan;
Nugent, Bridget;
Bandukwala, Abbas;
Schuck, Robert;
Tomita, York;
Pepe, Salvatore;
Doi, Mary;
Winiecki, Scott;
Lee, Kerry Jo

Publication type:

Article

The dalbavancin dilemma: Establishment of a new formulary restriction workflow to balance access and stewardship.

Published in:

American Journal of Health-System Pharmacy, 2025, v. 82, n. 10, p. 517, doi. 10.1093/ajhp/zxae387

By:

Stevens, Ryan W;
Bye, Katie;
Ausman, Sara;
Bartoo, Anna;
Noble, Jake;
Clement, Josh

Publication type:

Article

AI V. MQD: NAVIGATING NEW REGULATORY CHALLENGES IN THE LIFE SCIENCES.

Published in:

William & Mary Law Review, 2025, v. 66, n. 6, p. 1655

By:

Smith, Hayden W.

Publication type:

Article

Looking Toward the Future: Emerging Therapies for Hepatocellular Carcinoma.

Published in:

Gastroenterology & Hepatology, 2025, v. 21, p. 286

By:

Rao, Sanjana;
Prince, Sean-Patrick;
Gaddipati, Sirisha;
Feun, Lynn;
Ezenwajiaku, Nkiruka;
Martin, Paul;
Jones, Patricia D.

Publication type:

Article

Confirmatory Evidence Used in Non‐Oncologic Rare Disease New Molecular Entity Marketing Applications Approved by FDA, 2020–2023.

Published in:

Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 6, p. 1627, doi. 10.1002/cpt.3630

By:

Nugent, Bridget M.;
Ramamoorthy, Anuradha;
Pippins, Jennifer R.;
Pepe, Salvatore;
Doi, Mary;
Thomas, Audrey;
Bagheri, Brandon;
Welsh, Cynthia;
Madabushi, Rajanikanth;
Lee, Kerry Jo

Publication type:

Article

IQ Survey Results on Current Industry Practices: Part 2—Quantitative Evaluations of Immunogenicity Assessment.

Published in:

Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 6, p. 1605, doi. 10.1002/cpt.3573

By:

Richards, Susan;
Winzenborg, Insa;
Luedtke, Doreen;
Niu, Tao;
Hamuro, Lora;
Kowalski, Karey;
Leu, Jocelyn H.;
Yang, Jianning;
Ganti, Vaishnavi;
Bhattacharya, Indranil;
Gueorguieva, Ivelina;
Mostafa, Nael;
Grimaldi, Christine;
Wu, Benjamin

Publication type:

Article

Dose Determinations at Drug Approval Reviews: FDA‐Approved Drugs in Past 5 Years.

Published in:

Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 6, p. 1743, doi. 10.1002/cpt.3611

By:

Mita, Sachiko;
Ono, Shunsuke

Publication type:

Article

Advancing human-use experience for real-world evidence for the registration of traditional Chinese medicine products in China.

Published in:

BMC Complementary Medicine & Therapies, 2025, v. 25, n. 1, p. 1, doi. 10.1186/s12906-025-04906-x

By:

Xia, Mingge;
Xue, Yan;
Zhu, Luwei;
Chen, Xianwen;
Ung, Carolina Oi Lam;
Han, Sheng;
Lai, Yunfeng;
Hu, Hao

Publication type:

Article

Prostaglandin Intracameral Implants for Ocular Hypertension and Open-Angle Glaucoma.

Published in:

Journal of Pharmacy Technology, 2025, v. 41, n. 3, p. 144, doi. 10.1177/87551225251313707

By:

Cheng, Christine M.;
Rehmani, Cameron;
Chin, Jordan

Publication type:

Article

Trials special series - the collection, analysis and reporting of adverse events in randomised controlled trials.

Published in:

Trials, 2025, v. 26, n. 1, p. 1, doi. 10.1186/s13063-025-08861-3

By:

Phillips, Rachel;
Cornelius, Victoria

Publication type:

Article

Characteristics, clinical evidence and implementation effects of conditional approvals for drugs in China, a pooled analysis from 2020 to 2023.

Published in:

Frontiers in Pharmacology, 2025, p. 1, doi. 10.3389/fphar.2025.1501525

By:

Yang, Li;
Fan, Shuoxin;
Zhang, Jie;
Huang, Geyun;
Tang, Yaoyang;
Xue, Lijia

Publication type:

Article

FDA Grants Accelerated Approval to Combination Avutometinib and Defactinib for KRAS-Variant, Recurrent, Low-Grade Serous Ovarian Cancer.

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

Proportion of patients in phase 2 oncology trials receiving treatments that are ultimately approved.

Published in:

JNCI: Journal of the National Cancer Institute, 2025, v. 117, n. 5, p. 1056, doi. 10.1093/jnci/djaf013

By:

Ouimet, Charlotte;
Fodor, Bianca;
Paggio, Joseph C Del;
Kimmelman, Jonathan

Publication type:

Article

A reassuringly routine trial.

Published in:

British Journal of Dermatology, 2025, v. 192, n. 5, p. 787, doi. 10.1093/bjd/ljae468

By:

Albrecht, Joerg

Publication type:

Article

Revisiting surrogacy of pathological complete response for long-term survival in triple-negative breast cancer.

Published in:

JNCI Cancer Spectrum, 2025, v. 9, n. 2, p. 1, doi. 10.1093/jncics/pkaf022

By:

Yoshino, Toru;
Zhang, Zao;
Sato, Ryota;
Lipkowitz, Stanley;
Fujii, Takeo

Publication type:

Article

Lotilaner for Demodex Blepharitis: The Journey from Veterinary Use to Human Medicine.

Published in:

Journal of Ocular Pharmacology & Therapeutics, 2025, v. 41, n. 4, p. 173, doi. 10.1089/jop.2024.0145

By:

Sharma, Akanksha;
Sharma, Pankaj Kumar;
Kompella, Uday B.

Publication type:

Article

Advancements in Psychiatric Care: DSM-5-TR Revisions and Recent Psychopharmacological Developments.

Published in:

Journal of Psychosocial Nursing & Mental Health Services, 2025, v. 63, n. 5, p. 13, doi. 10.3928/02793695-20250214-02

By:

Hutson, Elizabeth;
Hardy, Lyons;
Ellington, Erin;
Crouse, Ericka L.

Publication type:

Article

Paxlovid for nonhospitalized patients with COVID‐19.

Published in:

Academic Emergency Medicine, 2024, v. 31, n. 6, p. 621, doi. 10.1111/acem.14896

By:

Johari, Fatima;
Verma, Rajesh

Publication type:

Article

The limits of innovation: Directly addressing known challenges is necessary to improve the real‐world experience of novel medications for opioid use disorder.

Published in:

Academic Emergency Medicine, 2023, v. 30, n. 12, p. 1285, doi. 10.1111/acem.14814

By:

Morgan, Jake R.;
Assoumou, Sabrina A.

Publication type:

Article

US FDA approves new Alzheimer's drug.

Published in:: Lamp (0047-3936), 2021, v. 78, n. 4, p. 39
Publication type:: Article

EU approves medical cannabis product for epilepsy.

Published in:: Lamp (0047-3936), 2019, v. 76, n. 10, p. 29
Publication type:: Article

Australians strongly support science.

Published in:: Lamp (0047-3936), 2017, v. 74, n. 9, p. 35
Publication type:: Article

The Latest Respiratory Care News.

Published in:: 2024
Publication type:: Product Review

CFTR Modulators Redefining Cystic Fibrosis Care in the Youngest Patients.

Published in:

RT: The Journal for Respiratory Care Practitioners, 2023, v. 36, n. 5, p. 10

By:

ARNETT, ALYX

Publication type:

Article

E-cigarettes: A Viable Option to Quit Smoking or a Controversial Alternative?

Published in:

RT: The Journal for Respiratory Care Practitioners, 2023, v. 36, n. 3, p. 20

By:

ARNETT, ALYX

Publication type:

Article

First RSV Vaccines Approved for Adults Age 60 and Older.

Published in:: RT: The Journal for Respiratory Care Practitioners, 2023, v. 36, n. 3, p. 5
Publication type:: Article

Market Analysis: The Impact of Cylinder-free Systems on Inhaled Nitric Oxide Delivery.

Published in:: RT: The Journal for Respiratory Care Practitioners, 2023, v. 36, n. 1, p. 18
Publication type:: Article

FDA Approves Merck's Pneumoccocal Vax.

Published in:: RT: The Journal for Respiratory Care Practitioners, 2021, v. 34, n. 5, p. 8
Publication type:: Article

First Peanut Allergy Drug Approved for Children Age 4-17.

Published in:: RT: The Journal for Respiratory Care Practitioners, 2020, v. 33, n. 1, p. 34
Publication type:: Article

Product Releases.

Published in:: 2019
Publication type:: Product Review

Product Releases.

Published in:: RT: The Journal for Respiratory Care Practitioners, 2019, p. 7
Publication type:: Article

The Latest Respiratory Care News.

Published in:: RT: The Journal for Respiratory Care Practitioners, 2019, v. 32, n. 3, p. 6
Publication type:: Article

The Latest Respiratory Care News.

Published in:: RT: The Journal for Respiratory Care Practitioners, 2018, v. 31, n. 6, p. 6
Publication type:: Article

GSK'S LABA/ICS TRIPLE-COMBO COPD THERAPY GETS EXPANDED INDICATION.

Published in:: RT: The Journal for Respiratory Care Practitioners, 2018, v. 31, n. 3, p. 14
Publication type:: Article

The Industry's Latest Respiratory Products.

Published in:: 2018
Publication type:: Product Review

BEST OF 2017: TOP STORIES OF THE YEAR.

Published in:: RT: The Journal for Respiratory Care Practitioners, 2017, v. 30, n. 8, p. 6
Publication type:: Article

The Latest Respiratory Care News.

Published in:: RT: The Journal for Respiratory Care Practitioners, 2016, v. 29, n. 11, p. 32
Publication type:: Article

Influenza 2016-2017.

Published in:: RT: The Journal for Respiratory Care Practitioners, 2016, v. 29, n. 11, p. 24
Publication type:: Article

FDA Panels Recommend Approval of Breo Ellipta for Adult Asthma, but Not Adolescent.

Published in:: RT: The Journal for Respiratory Care Practitioners, 2015, v. 28, n. 4, p. 34
Publication type:: Article

New Clinical Trials Underway for Pulmonary Arterial Hypertension.

Published in:

RT: The Journal for Respiratory Care Practitioners, 2014, v. 27, n. 11, p. 4

By:

Fratantoro, Mike

Publication type:

Article

Modulation of endocannabinoid system: Success lies in the failures.

Published in:

2018

By:

Kumar, Subodh;
Sarma, Phulen;
Kumar, Harish;
Prakash, Ajay;
Medhi, Bikash

Publication type:

Editorial

European Medicines Evaluation Agency.

Published in:

Indian Journal of Pharmacology, 2004, v. 36, n. 1, p. 50

By:

Singh, J.

Publication type:

Article

PINK PILLS AND ECONOMIC MAN.

Published in:

Hedgehog Review, 2016, v. 18, n. 1, p. 10

By:

Davis, Joseph E.

Publication type:

Article

An open science pathway for drug marketing authorization-Registered drug approval.

Published in:

2021

By:

Naudet, Florian;
Siebert, Maximilian;
Boussageon, Rémy;
Cristea, Ioana A.;
Turner, Erick H.

Publication type:

journal article

At the Forefront: Social Workers' Role in Psilocybin Treatment for Depression and Substance Misuse.

Published in:

Social Work, 2024, v. 69, n. 3, p. 297, doi. 10.1093/sw/swae019

By:

Parker, Claire;
Wood, Bethany Marie

Publication type:

Article

Inference and Decision Making for 21st-Century Drug Development and Approval.

Published in:

American Statistician, 2019, v. 73, p. 319, doi. 10.1080/00031305.2019.1566091

By:

Ruberg, Stephen J.;
Harrell, Frank E.;
Gamalo-Siebers, Margaret;
Price, Karen;
LaVange, Lisa;
Jack Lee, J.;
Peck, Carl

Publication type:

Article

News from the FDA.

Published in:

Patient Care (Print), 2007, v. 41, n. 1, p. 10

By:

Asch-Goodkin, Judith;
Kaplan, Deborah

Publication type:

Article

News from the FDA.

Published in:

Patient Care (Print), 2006, v. 40, n. 12, p. 10

By:

Asch-Goodkin, Judith;
Kaplan, Deborah

Publication type:

Article

What's ahead for the FDA?

Published in:: Patient Care (Print), 2006, v. 40, n. 12, p. 9
Publication type:: Article

News from the FDA.

Published in:

Patient Care (Print), 2006, v. 40, n. 10, p. 14

By:

Asch-Goodkin, Judith;
Kaplan, Deborah

Publication type:

Article