Corcept shares tumble after FDA letter reveals warnings before drug rejection

Shares of Corcept Therapeutics fell 16% on Friday after a corrected "complete response letter" from the U.S. Food ​and Drug ...
FiercePharma

‘Weak’ evidence and an ‘unpleasant’ odor: FDA sheds light on drug refusal process

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view into the high-stakes discussions that decide whether a medicine will ever make ...
Morningstar

Capricor: FDA Posting of Rejection Letter Didn't Include Response

Capricor Therapeutics is raising issues with the U.S. Food and Drug Administration's new policy of publishing rejection letters sent to drugmakers. The FDA in June began publishing older letters, ...
Becker's Hospital Review

FDA speeds up rejection letter posts

The FDA said Sept. 4 it will release complete response letters, or product rejection letters, “promptly after they are issued” to manufacturers. The agency also published 89 previously unreleased ...