A clear look at the 340B program: how hospitals generate revenue from drug discounts, why it has expanded, and the growing ...
Denali Therapeutics is the latest company to sell a priority review fast pass for an elevated price after the program was ...
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 ...
WASHINGTON (AP) — The Food and Drug Administration on Thursday announced the first round of experimental drugs that will receive drastically expedited reviews at the agency, part of an effort 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 ...
FDA’s draft “plausible mechanism” framework gives individualized genetic therapies a clearer path to market, but questions remain, write experts at Morrison Foerster.
The Food and Drug Administration Monday announced an initiative to encourage the use of RFID by drug companies. Mark your calendar: June 30, 2026 (10:00 a.m. PDT). A 37.5% ownership interest in ...
The Food and Drug Administration on Thursday announced the first round of experimental drugs that will receive drastically expedited reviews at the agency, part of an effort to prioritize medicines ...