The FDA closed out 2023 with rejections of three drugmaker applications.

The FDA closed out 2023 with rejections of three drugmaker applications for first approval or expanded use, issuing complete response letters to Amgen, Zealand Pharma, and Merck & Co. The rejected drugs were intended for treating cancer, low blood sugar, and chronic cough. Despite these setbacks, the FDA’s main review office approved 55 new drugs in 2023, the highest since 2018, reflecting the success of past investments in biotech startups and dealmaking. Notably, Amgen’s cancer drug Lumakras faces potential withdrawal in four years if clinical trials fail to prove its superiority over existing treatments. Zealand Pharma’s rejection was based on manufacturing deficiencies, while Merck’s gefipixant for chronic cough lacked substantial evidence of effectiveness in clinical trials. The FDA’s biologics office also achieved milestones, clearing the first vaccines for respiratory syncytial virus and the world’s first CRISPR medicine, among other gene therapies.