Exclusive: US FDA taps Merck drugs with blockbuster sales potential for national priority vouchers

The U.S. Food and Drug Administration is moving to fast-track reviews of two experimental Merck drugs with ...
BioSpace

FDA Mulls National Priority Vouchers for Two Potential Merck Blockbusters: Report

The tickets could go to the lipid-lowering pill enlicitide decanoate and the antibody-drug conjugate sacituzumab tirumotecan, ...
Becker's Hospital Review

FDA taps J&J drug for priority voucher program

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

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 ...
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.
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 ...
Food Safety News

New FDA programs designed to enhance transparency of outbreak investigations

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 ...
Physicians Committee for Responsible MedicineOpinion

Making Animal Experiments the Exception: The Physicians Committee’s Road to FDA Reform

In April 2025, the U.S. Food and Drug Administration (FDA) released its Roadmap to Reducing Animal Testing in Preclinical ...
MM&M

FDA’s new national priority voucher program wants to speed up drug approvals while lowering drug costs

FDA commissioner Dr. Marty Makary is beginning to make moves toward his promise of speeding up drug approval pathways at the agency. But he’s aiming to do things a bit differently than in the past — ...
MD&M East

FDA Expands Medical Device Recall Alert Program

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 ...