In 2023, FDA's CDER approved 55 new drugs, a five-year high. Key 2024 drug launches include KarXT for schizophrenia, Donanemab for Alzheimer's, Resmetirom for NASH, Sotatercept for PAH, Datopotamab deruxtecan for lung & breast cancer, Acoramidis for ATTR-CM, mRNA-1345 for RSV, Anktiva for NMIBC, Ensifentrine for COPD, and Imetelstat for MDS.