Hunter syndrome

Orange flag on top of a mountain
Favicon Fierce Pharma

FDA approves Denali's Hunter syndrome drug

In approving Avlayah, the FDA has greenlit the first treatment for Hunter syndrome that addresses the condition’s pernicious cognitive symptoms.
Darren Incorvaia Mar 25, 2026 2:50pm
MPS Families Carry Coffin to FDA

Rare disease advocates stage 'funeral' at FDA, make 4 demands

Mar 18, 2026 5:25pm
stack of letters mail envelopes

FDA details Regenxbio rare disease rejection

Mar 3, 2026 12:56pm
Image of a neon sign with the word no lit up next to an unlit yes

FDA rejects Regenxbio's Hunter syndrome gene therapy

Feb 9, 2026 4:05pm
king crown queen royalty monarchy gold winner top

Royalty's $275M financing deal for Denali drug awaiting FDA nod

Dec 4, 2025 10:20am
Clock in front of the subway

Denali's Hunter syndrome drug latest to be hit by FDA delay

Oct 14, 2025 8:09am