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 ...
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 ...
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 White House criticized a report questioning whether an application for the unapproved drug was for President Trump.
Denali Therapeutics is the latest company to sell a priority review fast pass for an elevated price after the program was ...
The US FDA has begun accepting applications for its pilot PreCheck program, which is designed to ease the process for pharma companies to build new manufacturing facilities in the US. The program is ...
Drug developers face new regulatory uncertainty because the status of a number of ambitious changes to FDA’s review processes are in doubt following the departure of Commissioner Marty Makary and many ...
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 ...
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