FDA refuse-to-file letter

Road closed and detour signs
Biotech

FDA refuses Axsome filing for former Pfizer fibromyalgia asset

Axsome is plotting another phase 3 trial to make up for a study that the FDA deemed inadequate and not well-controlled.
Darren Incorvaia Jun 9, 2025 12:27pm
Food and Drug Administration

Soligenix stock sinks as FDA refuses lymphoma application

Feb 14, 2023 10:15am
Lots of nos

BrainStorm shares tumble as FDA again knocks back ALS drug

Nov 10, 2022 10:05am
dominoes fall stop fail investigation

FDA refuses to review Aeglea's rare disease drug application

Jun 2, 2022 3:49pm
FDA

Plot twist: FDA pivots on Alkermes' depression drug

Apr 16, 2018 6:02pm
FDA

FDA refuses to review Alkermes’ depression drug

Apr 2, 2018 8:25am