drug approvals

AZ
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FDA's surprise approval of AZ's oral SERD sets new paradigm

Etcamah’s approval “validates an entirely new treatment paradigm of ctDNA-guided intervention before radiographic progression.”
Angus Liu Sep 8, 2026 10:35am
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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
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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