FDA clears Denali drug in ‘clear step’ for rare disease biotechs
BioPharma Dive
The approval of Denali s Hunter syndrome treatment, Avlayah, comes after a series of drug rejections and delays that had led to criticism of the FDA s stance on rare disease therapies.
pharminent
March 26, 2026 (Last updated: March 27, 2026)
BioPharma Dive
The approval of Denali s Hunter syndrome treatment, Avlayah, comes after a series of drug rejections and delays that had led to criticism of the FDA s stance on rare disease therapies.