BioSpace

Partner’s Bizengri cleared by FDA for ultra-rare cancer days after winning priority voucher

Partner Therapeutics announced last week that the FDA had granted Bizengri a Commissioner’s National Priority Voucher to ...
Fierce Pharma

Partner's bispecific Bizengri nabs FDA national priority nod in rare bile duct cancer

With the program’s seventh approval in the books, the FDA is illustrating just how speedy it can be with drug reviews that ...
Fierce Pharma

Sanofi asks to pull Tzield bid from FDA's controversial CNPV program: report

Since it was established nearly a year ago by the FDA, the Commissioner’s National Priority Voucher (CNPV) program has been ...
RAPS

Study: FDA’s expedited programs play increasing role in bringing novel drugs to market

Expedited development and review programs established by the US Food and Drug Administration (FDA) have a growing role in bringing drugs and biologics to market, with novel orphan and nonorphan ...
TwinCities.com

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 ...
STAT

Sanofi asks to pull diabetes drug out of FDA voucher program after political appointee interfered with review

Sanofi has asked the FDA to pull its type 1 diabetes drug out of Commissioner Marty Makary’s new speedy drug review program.
JD Supra

CMS and FDA Announce New RAPID Program for Medicare Coverage of Breakthrough Medical Devices

On April 23, 2026, the Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) jointly announced the ...
The National Law Review

FDA Issues New Produce Regulatory Program Standards

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
RAPS

Several FDA Programs to be Investigated in 2013 Under Proposed OIG Work Plan

The US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG), an investigative body charged with overseeing program performance and integrity, plans to devote part of ...