FDA refuse-to-file letter

Food and Drug Administration
Biotech

Soligenix stock sinks as FDA refuses lymphoma application

The agency has sent the biotech a refuse-to-file letter, leaving Soligenix scrambling to decide on a path to market as its stock sinks.
James Waldron 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
FDA

Celgene slips as FDA refuses to review critical MS drug ozanimod

Feb 28, 2018 9:20am