Ophthalmology Times4d
FDA accepts new drug application for low-dose atropine from Sydnexis
The FDA has set a PDUFA target action date of October 23, 2025, for the low-dose atropine formulation.
Zacks Small Cap Research on MSN5d
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 ...
FDA files Corcept’s NDA for Relacorilant as treatment in Hypercortisolism
Corcept Therapeutics (CORT) announced that the FDA filed its New Drug Application (NDA) submission for its proprietary, selective cortisol ...
Yahoo Finance13d
Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-05 in Alzheimer’s Disease Agitation Supporting NDA Submission
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 ...
Cytokinetics says FDA does not plan advisory committee meeting for aficamten NDA
In a regulatory filing, Cytokinetics (CYTK) disclosed that at upcoming investor conferences, the company will be providing, and is hereby ...
Business Wire5d
Sydnexis Announces FDA Acceptance of New Drug Application for SYD-101 for the Treatment of Progression of Pediatric Myopia
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 ...