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An FDA rejection letter for Corcept Therapeutics’ potential hormonal disorder drug says the agency told the company it had serious concerns before the application was submitted.
The complete response letter, released Friday, again shows how some companies have not fully explained the reasons behind a rejection decision in their public announcements. This is the first CRL the FDA has released in 2026, following the agency’s first-ever release of more than 200 rejection letters last year.
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