drug approvals

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Biotech

FDA halts release of new drug rejection letters

After a petition challenged the policy for its potential to publicize proprietary information, the FDA “temporarily paused” the effort in April.
Darren Incorvaia Jul 8, 2026 1:33pm
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CDER chief Høeg and CBER's Szarama exiting FDA posts

May 15, 2026 1:44pm
FDA
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FDA approves leucovorin without clinical trial—but not for autism

Mar 10, 2026 9:00am
FDA

FDA plans real-time release of drug rejection letters

Sep 4, 2025 1:45pm
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FDA's response letter salvo sheds light on drug refusal process

Jul 11, 2025 10:15am
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FDA shares more than 200 CRLs for now-approved drugs

Jul 10, 2025 10:54am