Successful drug discovery is like finding oases of safety and efficacy in chemical and
biological deserts. Screens in disease models, and other decision tools used in drug …

Important breakthroughs in medical treatments have improved outcomes for patients
suffering from several types of cancer. However, many oncological treatments approved by …

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 …

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 …

Fewer than half of new drugs have data on their comparative benefits and harms against
existing treatment options at the time of regulatory approval in Europe and the USA. Even …

Assessments of clinical evidence vary between regulators and health technology
assessment bodies, but precise differences remain unclear. To compare uncertainties raised …

Background Over the past decades, US Congress enabled the US Food and Drug
Administration (FDA) to facilitate and expedite drug development for serious conditions …

Background This study analyzes the development, US Food and Drug Administration (FDA)
approval, benefits, innovation, trials, epidemiology, and price of cancer drugs with multiple …

Background Accelerated approval (AA) of novel anticancer drugs based on surrogacy has
attracted considerable concern globally. China National Medical Products Administration …

Real-world evidence (RWE) has garnered great interest to support registration of new
therapies and label expansions by the United States Food and Drug Administration (FDA) …