The FDA has set a PDUFA target action date of October 23, 2025, for the low-dose atropine formulation.
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CING: April Pre-NDA Meeting
CING READ THE FULL CING RESEARCH REPORT Since the report of third quarter results, Cingulate, Inc. (NASDAQ:CING) has executed ...
Corcept Therapeutics (CORT) announced that the FDA filed its New Drug Application (NDA) submission for its proprietary, selective cortisol ...
today announced that it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA) supporting a supplemental NDA (sNDA) submission for AXS ...
In a regulatory filing, Cytokinetics (CYTK) disclosed that at upcoming investor conferences, the company will be providing, and is hereby ...
has accepted its New Drug Application (NDA) for SYD-101 and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 23, 2025. If approved, SYD-101 would be the first ...