A decade of FDA-approved drugs (2010–2019): trends and future directions

DG Brown, HJ Wobst - Journal of medicinal chemistry, 2021 - ACS Publications
A total of 378 novel drugs and 27 biosimilars approved by the US Food and Drug
Administration (FDA) between 2010 and 2019 were evaluated according to approval …

Brief overview of approaches and challenges in new antibiotic development: a focus on drug repurposing

NK Boyd, C Teng, CR Frei - Frontiers in cellular and infection …, 2021 - frontiersin.org
Drug repurposing, or identifying new uses for existing drugs, has emerged as an alternative
to traditional drug discovery processes involving de novo synthesis. Drugs that are currently …

FDA approval and regulation of pharmaceuticals, 1983-2018

JJ Darrow, J Avorn, AS Kesselheim - Jama, 2020 - jamanetwork.com
Importance US law requires testing of new drugs before approval to ensure that they provide
a well-defined benefit that is commensurate with their risks. A major challenge for the US …

Failure of investigational drugs in late-stage clinical development and publication of trial results

TJ Hwang, D Carpenter, JC Lauffenburger… - JAMA internal …, 2016 - jamanetwork.com
Importance Many investigational drugs fail in late-stage clinical development. A better
understanding of why investigational drugs fail can inform clinical practice, regulatory …

Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study

TJ Hwang, JS Ross, KN Vokinger, AS Kesselheim - bmj, 2020 - bmj.com
Objective To characterize the therapeutic value of new drugs approved by the US Food and
Drug Administration (FDA) and European Medicines Agency (EMA) and the association …

Characteristics of preapproval and postapproval studies for drugs granted accelerated approval by the US Food and Drug Administration

H Naci, KR Smalley, AS Kesselheim - Jama, 2017 - jamanetwork.com
Importance Drugs treating serious or life-threatening conditions can receive US Food and
Drug Administration (FDA) accelerated approval based on showing an effect in surrogate …

New drugs: where did we go wrong and what can we do better?

B Wieseler, N McGauran, T Kaiser - Bmj, 2019 - bmj.com
New drugs: where did we go wrong and what can we do better? Page 1 New drugs: where did
we go wrong and what can we do better? More than half of new drugs entering the German …

Cancer therapy approval timings, review speed, and publication of pivotal registration trials in the US and Europe, 2010-2019

MP Lythgoe, A Desai, B Gyawali, P Savage… - JAMA Network …, 2022 - jamanetwork.com
Importance Ensuring patients have access to safe and efficacious medicines in a timely
manner is an essential goal for regulatory agencies, one which has particular importance in …

Identifying mutations in epilepsy genes: impact on treatment selection

P Perucca, E Perucca - Epilepsy research, 2019 - Elsevier
The last decade saw impressive advances not only in the discovery of gene mutations
causing epilepsy, but also in unraveling the molecular mechanisms underlying the clinical …

[HTML][HTML] Clinical benefit, price and approval characteristics of FDA-approved new drugs for treating advanced solid cancer, 2000–2015

A Vivot, J Jacot, JD Zeitoun, P Ravaud, P Crequit… - Annals of …, 2017 - Elsevier
Background Prices of anti-cancer drugs are skyrocking. We aimed to assess the clinical
benefit of new drugs for treating advanced solid tumors at the time of their approval by the …