FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, Tuesday, April 22, 2025. (AP Photo/Jose Luis Magana, File) WASHINGTON (AP) — The Food and ...

Two government officials told STAT that the White House has been involved in final decisions about the FDA's new priority ...

The U.S. Food and Drug Administration approved on Tuesday the first drug under its new fast-track program designed to shorten review time for a drug application.

The Food and Drug Administration has launched a new transparency policy for the reporting of foodborne illness outbreak investigations. As part of the initiative the public, industry stakeholders and ...

WASHINGTON (AP) — The Food and Drug Administration on Thursday announced the first round of experimental drugs that will receive drastically expedited reviews at the agency, part of an effort to ...

FDA has expanded its early alert pilot program to cover all medical devices, according to a September 29 notice. In November 2024, the FDA’s Center for Devices and Radiological Health launched the ...

The U.S. Food and Drug Administration has introduced a new pilot program aimed at accelerating the review process for generic drugs that are both tested and produced entirely within the United States.

Big pharmaceutical companies are boosting their production capacity of branded medications with billions of dollars in new U.S. manufacturing plant construction, but generic drug production still ...

WASHINGTON (AP) — The Food and Drug Administration on Monday named a longtime pharmaceutical executive to run the agency’s drug program, the latest in a string of leadership changes at the agency. FDA ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months ...

Biohaven's troriluzole shows 50%-70% slowing of SCA disease progression, with FDA review now on track for Q4 2025 after a brief delay. FDA is no longer requiring an advisory committee meeting to ...