Browsing Tag
Supplemental NDA
2 posts
IntraBio files first-ever FDA application for an Ataxia-Telangiectasia drug with AQNEURSA sNDA submission
IntraBio filed the first-ever FDA application for Ataxia-Telangiectasia via an AQNEURSA sNDA. Read what the Phase III data means for patients and the rare disease market.
Vanda Pharmaceuticals (VNDA) wins FDA’s first formal drug approval hearing in 40 years as Hetlioz jet lag battle enters new phase
FDA grants Vanda Pharmaceuticals a rare Part 12 public hearing on Hetlioz jet lag rejection, the first such drug approval hearing in 40 years. Read the full analysis.