FDA refuse-to-file letter

Moderna
Biotech

Moderna hit with FDA refusal-to-file letter for mRNA flu shot

The FDA specifically took issue with the trial's control arm, which incorporated a "licensed standard-dose seasonal influenza vaccine," Moderna said.
Eric Sagonowsky Feb 10, 2026 7:45pm
Road closed and detour signs

FDA refuses Axsome filing for former Pfizer fibromyalgia asset

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