New Drug Application

accelerated

Biotech

FDA aims for September approval decision for Stealth's drug

The newfound urgency is likely fueled by a public outcry surrounding the FDA's several delays and subsequent refusal of the rare disease candidate.

Gabrielle Masson Aug 21, 2025 10:15am

clock delay wait time alarm

Regenxbio's Hunter gene therapy latest to face FDA delay

Aug 19, 2025 10:30am

Start Again written on a chalkboard on wooden table

Stealth Bio submits rare disease application for the third time

Aug 18, 2025 11:08am

Soccer ball flying into a net scoring a goal

Sellas’ AML asset tied to 50% response rate in certain patients

Jul 15, 2025 10:34am

Image of a neon sign with the word no lit up next to an unlit yes

FDA shares more than 200 CRLs for now-approved drugs

Jul 10, 2025 10:54am

Cartoon of humanoid robot sitting at computer working

FDA hopes AI can deliver 'rapid or instant' reviews

Jun 11, 2025 12:45pm