As the FDA's Commissioner's National Priority Voucher (CNPV) program has picked up steam, with 15 companies now having ...

FDA moves reshaping drug policy include fast-track programs, updated biosimilar guidance, and new rare disease approval pathways.

The FDA says it is hiring more than 1,000 new employees and rolling out a pilot communication program in efforts to speed up the review of new drugs. | The FDA is hiring more than 1,000 new employees ...

The agency says agentic AI deployment will enable its staff to further advance the use of AI to assist with more complex ...

FDA launches digital health pilot to ease regulations and boost innovation in managing chronic diseases like heart failure and depression.

Richard Pazdur, the new director of the Center for Drug Evaluation and Research, raised concerns amid the rollout of several ...

Pazdur reportedly questioned whether a new FDA program called the Commissioner’s National Priority Voucher, designed to speed reviews for drugs tied to national priorities, was transparent or even ...

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 ...

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 ...

The name “340B” comes from the section of the U.S. Public Health Service Act of 1992 that requires pharmaceutical ...