Ophthalmology Times2d
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.
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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 ...
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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 ...
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 ...
CURE16d
FDA Accepts NDA For Dordaviprone in H3 K27M-Mutant Diffuse Glioma
A New Drug Application has been accepted seeking accelerated approval for dordaviprone for patients with recurrent H3 ...
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 ...