All articles tagged with #fda approvals
In 2025, the FDA approved 46 new therapeutic agents, including a diverse range of modalities such as biologics, kinase inhibitors, and gene therapies, with cancer remaining the most common therapeutic area. The year was marked by policy changes, staffing challenges, and the launch of new approval pathways, reflecting a tumultuous but innovative period for drug development.
The FDA approved 55 new drugs in 2023, marking a significant increase from the previous year and setting a 10-year rolling average high. Oncology led with 24% of the approvals, followed by neurology. Notable approvals included the first CRISPR–Cas9-based gene editing product, two RSV vaccines, and a burst of gene therapies. AstraZeneca's capivasertib became the first AKT inhibitor approved for breast cancer, and several first-in-class cancer therapies were greenlit. In neurology, Biogen and Ionis's tofersen received accelerated approval for SOD1-mutated ALS, and Eisai and Biogen's lecanemab was approved for Alzheimer's disease. The approvals spanned various modalities, including nucleotide-based therapeutics and T-cell engaging bispecific antibodies.