Food and Drug Administration (FDA)

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Biotech

FDA plans to release more CRLs as controversial policy resumes

After 14 new rejection letters were published last week following a three-month pause, the FDA today confirmed that the policy has resumed.

Darren Incorvaia Jul 14, 2026 2:50pm

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FDA releases 14 drug rejection letters after 3-month pause

Jul 13, 2026 11:01am

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FDA halts release of new drug rejection letters

Jul 8, 2026 1:33pm

FDA

FDA gene therapy regulator steps down from leadership role

Jun 30, 2026 10:36am

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Praxis faces FDA delay, analysts point finger at agency layoffs

Jun 30, 2026 4:13am

Kyle Diamantas

HHS unveils plan to speed up ph. 1 trials by 6 to 12 months

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