drug approvals

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CDER chief Høeg and CBER's Szarama exiting FDA posts

With the ink barely dry on outgoing commissioner Marty Makary’s resignation, more top regulators are heading for the exit at the FDA.
FDA
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FDA approves leucovorin without clinical trial—but not for autism

Mar 10, 2026 9:00am
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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
Image of a neon sign with the word no lit up next to an unlit yes

FDA shares more than 200 CRLs for now-approved drugs

Jul 10, 2025 10:54am
positive negative up down good bad mixed

FDA single-trial guidance calls for the good, bad and ugly data

Sep 19, 2023 10:15am