FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower ...

It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually determined after an approval in the U.S.

In June 2025, the US Food and Drug Administration (FDA) announced a major update to its General Food Labeling Requirements Compliance Program—the first overhaul of this program since 2010.

The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and unnecessary delays in the regulatory process.

The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as replies to drug and biological product applications submitted to the ...

Georgia's congressional delegation is advocating for FDA reconsideration of the drug elamipretide for Hope Filchak.

Specifically, the FDA removed the Risk Evaluation and Mitigation Strategy (REMS) program requirements from two BCMA-directed CAR T-cell therapies for multiple myeloma — ciltacabtagene autoleucel ...

Hundreds of chemicals banned in Europe remain in American foods while FDA oversight remains limited. FBI says it's uncovered largest medical fraud in US history Ex-Dolphin Raheem Mostert Reacts to ...

SAN FRANCISCO (KPIX) — With the FDA recently rejecting a drug application that aims to help those living with Barth Syndrome, one Bay Area family is frustrated by the delay of approved ...