House lawmaker raises new concerns over FDA’s ultra-fast drug review program

FDA Commissioner Marty Makary’s initiative promises ultra-fast reviews for drugs aligning with “national priorities.” ...
STAT

FDA Commissioner Marty Makary tries to soothe staff concerns over voucher program

At an employee town hall, FDA leaders tried to quell staff concerns about a controversial new program to fast-track certain drugs.
BioSpace

Disc’s FDA Rejection Raises Questions About Commissioner’s Vouchers

FDA vouchers are normally a coveted prize for biopharma companies, but a surprise rejection for Disc Medicine’s rare disease drug has biopharma reconsidering.
Yahoo

Legal questions swirl around FDA's new expedited drug program, including who should sign off

WASHINGTON (AP) — The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the ...
BioProcess International

FDA rare disease fast-track program passes Senate in big win for small biotechs

The milestone is being celebrated as a “huge moment” for rare disease drug development.
Fierce Pharma

FDA’s rare pediatric disease voucher program revived by 2026 government funding bill

The Consolidated Appropriations Act of 2026, signed by Trump on Feb. 3, includes a provision reinstating the Mikaela Naylon ...
BioSpace

FDA’s Commissioner’s Priority Voucher Program ‘Shrouded in Secrecy,’ Democratic Rep Says

Rep. Jake Auchincloss of Massachusetts said the Commissioner’s National Priority Voucher program did not receive congressional backing. The FDA has also not yet made disclosures for eight senior ...

FDA breakthrough program starts FY2026 at steady pace

Orthopedics was the most active area over the second half of calendar 2025, with the FDA issuing 13 breakthrough designations to devices in the therapeutic area.