drug approvals

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Biotech

FDA releases 14 drug rejection letters after 3-month pause

The agency announced a plan to publish CRLs in real-time last fall, but suspended the practice in April after a citizen petition was filed.
Darren Incorvaia Jul 13, 2026 11:01am
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FDA halts release of new drug rejection letters

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