Denali Therapeutics is the latest company to sell a priority review fast pass for an elevated price after the program was ...

The listening session, held on the FDA’s White Oak Campus, featured 17 speakers representing patient groups, drug companies, ...

Medicare's upcoming weight-loss drug program could create major bottlenecks for doctors as millions of seniors seek access to ...

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 ...

Two members of Congress launched an investigation into FDA Commissioner Marty Makary, MD, MPH, and his use of "priority vouchers" for expedited drug approvals, suggesting that the voucher program ...

Ocular Therapeutix, Inc. OCUL stock is trading higher on Wednesday as the company prepares for its Investor Day, where it ...

A clear look at the 340B program: how hospitals generate revenue from drug discounts, why it has expanded, and the growing ...

FDA’s draft “plausible mechanism” framework gives individualized genetic therapies a clearer path to market, but questions remain, write experts at Morrison Foerster.

But from the get-go, the program has been plagued by confusion. Critics say the listed priorities are overly vague, the application review process is opaque, and, crucially, the program bears marks of ...

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 ...

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 ...