Agency staff "strongly recommended" a sham surgery-controlled trial be conducted before an approval filing, a stance one ...
Shares of uniQure plummeted more than 40% in premarket trading Monday after the company confirmed the FDA has rejected its ...
AMT-130 Huntington’s gene therapy data, FDA Phase III sham-trial push, cash runway, and 2026 catalysts—read now.
The Food and Drug Administration (FDA) has backtracked its initial decision last week of refusing to review Moderna’s mRNA ...
NRx together with Osmind, Inc. conducted an in-person meeting attended by leadership of the FDA Division of Psychiatry Products and leadership of ...
At a September 30, 2025, public meeting hosted by the U.S. Food and Drug Administration (FDA), industry stakeholders expressed strong support for the newly launched FDA PreCheck Program, while raising ...
Adial Pharmaceuticals, Inc. (NASDAQ:ADIL) on Tuesday received the final meeting minutes from its End of Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration (FDA) held in July. The ...
Moderna said after a “Type A” meeting, the agency agreed to move forward and review its application for the mRNA-based shot.
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