Browsing Tag
FDA Review
2 posts
FDA delay shifts Neurizon Therapeutics (ASX: NUZ) ALS trial start — Can Q4 still deliver a win?
FDA delays decision on Neurizon’s NUZ-001 ALS trial to October, but manufacturing, regulatory, and trial readiness milestones keep Q4 start within reach.
FDA extends deadline for Incyte’s Opzelura cream review in pediatric eczema following submission of new manufacturing data
Incyte (NASDAQ: INCY) faces FDA review delay for Opzelura® cream in children aged 2–11 with eczema, following CMC data submission. Decision now due September 2025.