Jan 28 (Reuters) - Regenxbio said on Wednesday the U.S. Food and Drug Administration has placed a clinical hold on two of its ...

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 ...

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

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.

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 ...

More than half a dozen major drugmakers are participating in the Trump administration's speedier review program for new ...

U.S. regulators will begin offering faster reviews to new medicines that administration officials deem as promoting “the health interests of Americans,” under a new initiative announced Tuesday. Food ...

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

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 ...

FDA’s stated reason for the recent reversal: the precert program is going to be so darn good we don’t need to exempt low risk products from FDA regulation. To be clear, FDA is not saying that it will ...