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FDA refuse-to-file letter
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
BrainStorm shares tumble as FDA again knocks back ALS drug
Nov 10, 2022 10:05am
FDA refuses to review Aeglea's rare disease drug application
Jun 2, 2022 3:49pm
Plot twist: FDA pivots on Alkermes' depression drug
Apr 16, 2018 6:02pm
FDA refuses to review Alkermes’ depression drug
Apr 2, 2018 8:25am
Celgene slips as FDA refuses to review critical MS drug ozanimod
Feb 28, 2018 9:20am