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 agency, stoking worries ...

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on drugs cleared under a new plan to slash FDA drug review times.

The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies ...

On September 29, 2025, the U.S. Food and Drug Administration (FDA) announced the expansion of its Early Alert program to include all medical devices. This expansion builds on a pilot program that ...

By Maggie Fick and Patrick Wingrove SAN FRANCISCO, Jan 16 (Reuters) - More than half a dozen major drugmakers are participating in the Trump administration's speedier review program for new medicines, ...

On October 3, 2025, the U.S. Food and Drug Administration (FDA) unveiled a pilot prioritization program that provides for accelerated review of abbreviated new drug applications (ANDAs) for generic ...

After a patient safety signal and then death, the FDA in October 2025 placed holds on two of the company’s CRISPR programs ...

Marty Makary’s program is causing new anxiety and confusion among staff already rocked by layoffs, buyouts and leadership upheavals, according to seven current or recently departed staffers. The ...

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 ...