The agency says pairing drug sponsors with research institutions could cut development timelines by 6 to 12 months ...
WASHINGTON — Federal health officials announced a pilot program Monday to speed up early-stage clinical trials, which they ...
Questions are swirling over Donald Trump’s health after a bombshell report about how one man got an unprecedented access to a ...
Denali Therapeutics is the latest company to sell a priority review fast pass for an elevated price after the program was ...
On Wednesday, the U.S. Food and Drug Administration (FDA) published three new draft guidances that aim to offer greater clarity to sponsors of cell and gene therapies (CGTs) on issues related to ...
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 ...
FDA’s draft “plausible mechanism” framework gives individualized genetic therapies a clearer path to market, but questions remain, write experts at Morrison Foerster.
A new independent analysis of the US Food and Drug Administration's (FDA) workload around biosimilars over the first three years shows how biosimilar development has slowly progressed as companies ...
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 ...
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 ...
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