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FDA ends busy year with three drug rejections

January 2, 2024


The Food and Drug Administration closed out 2023 with rejections of three drugmaker applications for first approval or expanded use, handing Amgen, Zealand Pharma and Merck & Co. complete response letters for medicines to treat cancer, low blood sugar and chronic cough.

The rejections came at the end of a year in which the regulator’s main review office approved 55 new drugs, the most since 59 were approved in 2018, as past years’ investment in biotech startups and dealmaking paid off with products that succeeded in clinical testing. The FDA’s biologics office also cleared 15 medicines.

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