Results 51 to 60 of about 4,829,888 (359)

Food and Drug Administration Approval Summary: Odevixibat (Bylvay) for the Treatment of Pruritus With Progressive Familial Intrahepatic Cholestasis

Gastro Hep Advances
On July 20, 2021, the Food and Drug Administration approved odevixibat (Bylvay) for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). PFIC is a rare disease that results in impaired
Sojeong Yi, Insook Kim, Rebecca Hager, Marian M. Strazzeri, Lili Garrard, Toru Matsubayashi, Ruby Mehta   +6 more
doaj   +1 more source

Overview of drugs approved by the FDA in 2022

Фармация и фармакология (Пятигорск), 2023
The aim of the work is to conduct a review of medications approved by the FDA in 2022.Materials and methods. In searching for the materials to write this review article, bibliographic databases including PubMed, Google Scholar and e-library.ru were ...
D. V. Kurkin, E. I. Morkovin, D. A. Bakulin, Yu. V. Gorbunova, Yu. A. Kolosov, M. A. Dzhavakhyan, I. E. Makarenko, R. V. Drai, A. V. Zaborovsky, O. V. Shatalova, A. V. Strygin, V. I. Petrov, A. P. Pleten, A. A. Prokopov, T. Yu. Tatarenko-Kozmina   +14 more
doaj   +1 more source

FDA Drug Approval Summaries: Fulvestrant

The Oncologist, 2002
Abstract Patients with hormone-sensitive breast cancer who have responded to tamoxifen may receive additional benefit from a second endocrine agent following progression or relapse after tamoxifen therapy. Fulvestrant (Faslodex®, ICI 182780, AstraZeneca Pharmaceuticals; Wilmington, Delaware) is a selective antagonist of estrogen designed
Peter F, Bross, Martin H, Cohen, Grant A, Williams, Richard, Pazdur   +3 more
openaire   +2 more sources

Evaluation of orally disintegrating tablets: regulatory pathways, administration practices and harmonization of bioequivalence study design

AAPS Open
Orally disintegrating tablets (ODTs) are a solid oral dosage form designed to rapidly disintegrate in the mouth without the need for water, improving patient compliance—particularly among pediatric, geriatric, and dysphagic populations.
Shapali Bagde, Xinyuan Xi, Heather Boyce, Myong-Jin Kim   +3 more
doaj   +1 more source

Effect of Antioxidants in Medicinal Products on Intestinal Drug Transporters

Pharmaceutics
The presence of mutagenic and carcinogenic N-nitrosamine impurities in medicinal products poses a safety risk. While incorporating antioxidants in formulations is a potential mitigation strategy, concerns arise regarding their interference with drug ...
Chetan P. Kulkarni, Jia Yang, Megan L. Koleske, Giovanni Lara, Khondoker Alam, Andre Raw, Bhagwant Rege, Liang Zhao, Dongmei Lu, Lei Zhang, Lawrence X. Yu, Robert A. Lionberger, Kathleen M. Giacomini, Deanna L. Kroetz, Sook Wah Yee   +14 more
doaj   +1 more source

2022 FDA TIDES (Peptides and Oligonucleotides) Harvest

Pharmaceuticals, 2023
A total of 37 new drug entities were approved in 2022; although that year registered the lowest number of drug approvals since 2016, the TIDES class consolidated its presence with a total of five authorizations (four peptides and one oligonucleotide ...
Othman Al Musaimi, Danah Al Shaer, Fernando Albericio, Beatriz G. de la Torre   +3 more
doaj   +1 more source

US Food and Drug Administration Approvals of Drugs and Devices Based on Nonrandomized Clinical Trials: A Systematic Review and Meta-analysis [PDF]

, 2019
IMPORTANCE The size of estimated treatment effects on the basis of which the US Food and Drug Administration (FDA) has approved drugs and devices with data from nonrandomized clinical trials (non-RCTs) remains unknown.OBJECTIVES To determine how often ...
Chalmers, Iain, Djulbegovic, Benjamin, Glasziou, Paul, Ioannidis, John P A, Klocksieben, Farina A, Razavi, Marianne   +5 more
core   +1 more source

Clinical Perspective of FDA Approved Drugs With P-Glycoprotein Inhibition Activities for Potential Cancer Therapeutics

Frontiers in Oncology, 2020
P-glycoprotein (also known as multidrug resistance protein 1 (MDR1) or ATP-binding cassette sub-family B member 1 (ABCB1) plays a crucial role in determining response against medications, including cancer therapeutics.
Jiun-I. Lai, Yu-Jhen Tseng, Ming-Huang Chen, Chi-Ying F. Huang, P. Chang   +4 more
semanticscholar   +1 more source

Real‐World Pediatric Blinatumomab Administration: Access to Outpatient Care Delivery and Impact of a Hospital‐Dispensed Model

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Blinatumomab has been shown to be highly effective for patients with pediatric B‐ALL and has recently become standard of care therapy. Due to its past use in the clinical trial setting, there is limited information available about real‐world administration.
Katelyn Oranges, Kelly A. Duffy, Sara McDonough, Evelyn Kurpiewski, R. Jennifer Randall, Allison Barz Leahy, Haley M. Newman, Joyce P. Lee, Stephen P. Hunger, Anne F. Reilly, David T. Teachey, Susan R. Rheingold, Daniel J. Zheng   +12 more
wiley   +1 more source

Standardizing bioequivalence administration methods for chewable tablets: aligning product-specific guidance with current FDA recommendations

AAPS Open
This paper examines the standardization of bioequivalence (BE) administration methods for chewable tablets and other dosage forms instructing chewing in alignment for generic drug development.
Hye Lim Lim, Heather Boyce, Qi Zhang, Myong-Jin Kim, Wei-Jhe Sun   +4 more
doaj   +1 more source