A Democratic lawmaker is raising new concerns about a Food and Drug Administration program designed to drastically shorten ...

FDA issued a CRL to Pharming's Joenja child use filing, citing dosing concerns in lower-weight kids and testing issues.

By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to ...

FDA drug alerts in endocrinology, including drug approvals, drug warnings, FDA medical device recalls, and FDA drug label ...

FDA PreCheck pilot aims to speed U.S. pharma plant construction and approvals for critical medicines with earlier feedback.

WASHINGTON (AP) — The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the ...

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...

The US Food and Drug Administration’s longtime oncology chief has filed to retire from the agency just weeks after he was chosen to lead the FDA’s drug division, according to four people familiar with ...

Established drugs were repurposed, “me-too” drugs were approved, and even the few new biological approaches lacked clinical ...

The U.S. Food and Drug Administration (FDA) has been rocked by recent changes to several leadership roles while it has grappled with how to handle new vaccine guidance. The agency has changed — five ...

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. These highlights were written by the reporters and editors ...

Defining precisely where drugs engage their targets in vivo is essential for understanding efficacy and toxicity. However, mapping in vivo drug targets with spatial and cellular resolution remains ...