US FDA approves first drug under new fast-track review program

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

Exclusive-US FDA brass pushed internally for speedier Lilly weight-loss pill verdict

Food and Drug Administration have pressed internally for reviewers to speed up their evaluation of Eli Lilly's experimental ...
Becker's Hospital Review

FDA grants 1st approval under priority voucher program

FDA grants 1st approval under priority voucher program to Augmentin XR, expediting review and supporting U.S. antibiotic supply chain resilience.
Becker's Hospital Review

Lawmakers raise concerns over FDA drug voucher program

Lawmakers raise concerns over FDA drug voucher program citing safety risks, transparency issues, and legal questions in a Nov. 20 letter to agency leaders.
MedTech Dive

FDA pilots allowing digital health devices access to CMS payment program

Companies can ask the FDA to waive premarket authorization and investigational device requirements while they collect ...
WBAL-TV

FDA to offer faster drug reviews to companies promoting 'national priorities'

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 ...
JD Supra

FDA Expands Early Alert Program to All Medical Devices

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 ...
JD Supra

FDA Commissioner Launches Pilot Program To Speed Review of Certain Drugs

On June 17, 2025, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary announced that the agency is creating a new pilot program called the Commissioner’s National Priority Voucher (CNPV) ...
BioSpace

Saol To Pitch Ultrarare Disease Drug as “Poster Child” for RDEP Program

Saol Therapeutics received a complete response letter for its pyruvate dehydrogenase complex deficiency treatment a week ...
Yahoo

FDA names former pharmaceutical company executive to oversee US drug program

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 ...