The FDA has renewed calls for Amgen’s Tavneos to be pulled from the market, saying it has discovered new evidence that study ...

The first-of-its-kind pilot could lead to speedier regulatory approval of medical drugs and devices and potentially reduce ...

The US Food and Drug Administration plans to cut the time it takes drug companies to test new medicines by getting more ...

Pivotal trial on avacopan was negative before actions of unblinded study personnel, agency ...

By Ahmed Aboulenein WASHINGTON, April 28 (Reuters) - The U.S. Food and Drug Administration launched a pilot program on Monday ...

The FDA has moved to pull Tavneos (avacopan) from the U.S. market, alleging that manipulated clinical trial data propped up ...

Consolidating adverse event databases is a smart move, but without public education, real-time transparency risks becoming ...

The FDA is testing real-time clinical trial reporting in an effort to speed up the drug review and approval process.

Tavneos’ original developer hid a study analysis and then altered data, the FDA alleged. Elsewhere, Erasca’s RAS drug was met with skepticism and Rocket Pharma sold a voucher.

FDA drug alerts in infectious diseases, including new drug approvals, safety warnings, recalls, and changes in indications.

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.