The US Food and Drug Administration (FDA) has released draft guidance aimed at assisting pharmaceutical manufacturers in transitioning from animal studies to non-animal alternatives for drug ...

The manufacturer of popular weight-loss drugs Ozempic and Wegovy, Novo Nordisk, is taking heat from the federal government for regularly failing to report potential side effects of its GLP-1 ...

March 11 (Reuters) - The U.S. Food and Drug Administration said on Wednesday it has introduced a unified platform ‌designed to streamline the analysis of reports on drug side effects. Sign up here.

FIRST ON FOX: The Food and Drug Administration (FDA) rolled out a new platform, backed by artificial intelligence, that will streamline publicly accessible reporting of negative or unexpected health ...

The US Food and Drug Administration (FDA) announced it is unifying its various adverse reporting systems into a single system called the Adverse Event Monitoring System (AEMS). The agency said the ...

A key US Republican senator said he’s launched an investigation into the Food and Drug Administration’s recent denials of treatments for rare diseases, adding political pressure on an agency that’s ...

Need something for a headache? Picking up a prescription? We have had the luxury in this country of knowing that the medications we need to take have been well researched by competent scientists with ...

UniQure needs to run another study to prove its gene therapy "actually helps people with Huntington's disease," a senior FDA official said. The official said UniQure is the "latest company to make a ...

In a highly unusual move for a normally buttoned-up regulatory agency, a senior official with the US Food and Drug Administration held a call with reporters Thursday to defend the agency’s recent ...

WASHINGTON (AP) — The head of the Food and Drug Administration plans to start offering bonus payments to agency drug reviewers who complete their work ahead of schedule, the latest in a flurry of ...

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...

Ana Santos Rutschman does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations ...