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Cell & Gene Therapy
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Oncology
Venture Capital
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Medtech
Devices
Diagnostics
AI and Machine Learning
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Trending
Biologics
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Drug Development
Small Molecule Research & Development
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Marty Makary
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
FDA releases 14 drug rejection letters after 3-month pause
Jul 13, 2026 11:01am
FDA halts release of new drug rejection letters
Jul 8, 2026 1:33pm
FDA appears less prickly toward Moderna mRNA flu shot
Jun 16, 2026 2:46pm
Makary FDA reforms ‘continue to move forward’ despite turmoil
May 26, 2026 10:27am
Fierce Pharma
CDER chief Høeg and CBER's Szarama exiting FDA posts
May 15, 2026 1:44pm