IMPLICATIONS OF THE FDA APPROVAL OF PCSK9 INHIBITORS FOR CONTEMPORARY CARDIOVASCULAR PRACTICE: FINDINGS FROM THE NCDR® RESEARCH TO PRACTICE (R2P) PROJECT
Sign Up to like & getrecommendations! Published in 2017 at "Journal of the American College of Cardiology"
DOI: 10.1016/s0735-1097(17)35050-7
Abstract: Background: In 2015, the FDA approved PCSK9 inhibitors for patients with either familial hypercholesterolemia (FH) or clinical atherosclerotic cardiovascular disease (ASCVD) on maximally tolerated statin therapy who “require additional lowering of LDL.” The proportion of… read more here.
Keywords: fda approval; pcsk9 inhibitors; inhibitors contemporary; practice ... See more keywords
You can now search FDA approval documents easily at fda.opentrials.net
Sign Up to like & getrecommendations! Published in 2017 at "British Medical Journal"
DOI: 10.1136/bmj.j677
Abstract: Good progress has been made since Turner’s paper on how to find data on the Food and Drug Administration’s website was published in 2013.1 We have now made a public facing tool that makes … read more here.
Keywords: documents easily; search fda; fda approval; easily fda ... See more keywords
Abstract 4147077: Early Reported Events with the TriClip™ System for Transcatheter Tricuspid Valve Repair: Insights from FDA's MAUDE Database
Sign Up to like & getrecommendations! Published in 2024 at "Circulation"
DOI: 10.1161/circ.150.suppl_1.4147077
Abstract: Background: Tricuspid regurgitation (TR) worsens heart failure symptoms and perpetuates right ventricular failure (RVF). Given the limited efficacy of medicines and high risk of surgical mortality, percutaneous therapeutic options are gaining importance. The TRILUMINATE study… read more here.
Keywords: system; triclip; maude database; fda approval ... See more keywords
The Long and Winding Road After FDA Approval: A Medical Device Industry Perspective.
Sign Up to like & getrecommendations! Published in 2017 at "Circulation"
DOI: 10.1161/circulationaha.117.024633
Abstract: > The road is long > > With many a winding turn > > That leads us to who knows where > > Who knows where > > —“He Ain’t Heavy, He’s My Brother,” by… read more here.
Keywords: fda approval; industry; road; long winding ... See more keywords
Real World Use of IDH2- Targeted Inhibitors in a Single Academic Medical Center Experience Since Enasidenib FDA-Approval
Sign Up to like & getrecommendations! Published in 2019 at "Blood"
DOI: 10.1182/blood-2019-125135
Abstract: Background Enasidenib, a novel inhibitor of isocitrate dehydrogenase 2 (IDH2), offers targeted therapy to the ~12% of acute myeloid leukemia (AML) patients in which a recurrent IDH2 mutation exists. While currently only FDA approved for… read more here.
Keywords: clinical trial; fda approval; disease; idh2 ... See more keywords
Prediction of Drug Approval After Phase I Clinical Trials in Oncology: RESOLVED2.
Sign Up to like & getrecommendations! Published in 2019 at "JCO clinical cancer informatics"
DOI: 10.1200/cci.19.00023
Abstract: PURPOSE Drug development in oncology currently is facing a conjunction of an increasing number of antineoplastic agents (ANAs) candidate for phase I clinical trials (P1CTs) and an important attrition rate for final approval. We aimed… read more here.
Keywords: drug; phase clinical; clinical trials; fda approval ... See more keywords
12-month uptake of PD-L1 testing and atezolizumab (atezo) + nab-paclitaxel (nab-pac) treatment in metastatic triple-negative breast cancer (mTNBC) following accelerated FDA-approval in the United States.
Sign Up to like & getrecommendations! Published in 2020 at "Journal of Clinical Oncology"
DOI: 10.1200/jco.2020.38.15_suppl.e13103
Abstract: e13103Background: In March 2019, atezo + nab-pac received accelerated FDA-approval for the treatment (tx) of patients (pts) with unresectable locally advanced or metastatic TNBC who express PD-L1 i... read more here.
Keywords: atezo nab; accelerated fda; fda approval; nab pac ... See more keywords
Patterns of immune checkpoint inhibitor utilization and PD-L1 testing in advanced gastroesophageal cancers using real-world data.
Sign Up to like & getrecommendations! Published in 2025 at "Journal of Clinical Oncology"
DOI: 10.1200/jco.2025.43.4_suppl.370
Abstract: 370 Background: Globally, gastroesophageal cancer (GEC) is a leading cause of morbidity and mortality, with poor 5-year overall survival (OS). The addition of immune checkpoint inhibitors (ICIs) such as nivolumab and pembrolizumab to chemotherapy has… read more here.
Keywords: time; fda approval; utilization; approval ... See more keywords
Pseudomonas Exotoxin-Based Immunotoxins: Over Three Decades of Efforts on Targeting Cancer Cells With the Toxin
Sign Up to like & getrecommendations! Published in 2021 at "Frontiers in Oncology"
DOI: 10.3389/fonc.2021.781800
Abstract: Cancer is one of the prominent causes of death worldwide. Despite the existence of various modalities for cancer treatment, many types of cancer remain uncured or develop resistance to therapeutic strategies. Furthermore, almost all chemotherapeutics… read more here.
Keywords: cancer; moiety; cancer cells; pseudomonas exotoxin ... See more keywords
Breakthrough Therapy Cancer Drugs and Indications With FDA Approval: Development Time, Innovation, Trials, Clinical Benefit, Epidemiology, and Price.
Sign Up to like & getrecommendations! Published in 2024 at "Journal of the National Comprehensive Cancer Network : JNCCN"
DOI: 10.6004/jnccn.2023.7110
Abstract: BACKGROUND The breakthrough therapy designation (BTD) facilitates the development of drugs with a large preliminary benefit in treating serious or life-threatening diseases. This study analyzes the FDA approval, trials, benefits, unmet needs, and pricing of… read more here.
Keywords: epidemiology; cancer; drugs indications; fda approval ... See more keywords