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.

Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and ...

The FDA awarded two national priority review vouchers through its Commissioner's National Priority Voucher pilot program on Dec. 19, bringing the ...

The FDA taps J&J drug teclistamab for its National Priority Voucher pilot, enabling expedited review for multiple myeloma treatment.

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 ...

Companies can ask the FDA to waive premarket authorization and investigational device requirements while they collect real-world data in a CMS program.

Back in February, newly-confirmed Secretary of Health and & Human Services (HHS) Robert F. Kennedy Jr. promised to reverse decades of industry capture ...

SAN FRANCISCO, CA / ACCESS Newswire / September 30, 2025 / Jaguar Health (NASDAQ:JAGX) today announced that Jaguar family company Napo Pharmaceuticals (Napo) is providing the company’s novel ...