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Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-05 in Alzheimer’s Disease Agitation Supporting NDA Submission
The purpose of the meeting was to reach agreement with the FDA on the proposed content and format of the Company’s planned sNDA submission including the clinical and nonclinical requirements.
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FDA approves scPharmaceuticals’ Furoscix sNDA for oedema in CKD
The US Food and Drug Administration (FDA) has approved scPharmaceuticals’ supplemental new drug application (sNDA) for ...
Axsome Therapeutics gets FDA support to submit sNDA for its Alzheimer’s disease agitation treatment
Axsome Therapeutics (NASDAQ:AXSM) said on Monday that in the FDA meeting minutes, the agency has supported a supplemental NDA ...
Axsome Therapeutics expects to submit sNDA for AXS-05 in Q3
Axsome Therapeutics (AXSM) has received formal pre-New Drug Application meeting minutes from the U.S. Food and Drug Administration supporting a ...
Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-05 in Alzheimer’s Disease Agitation Supporting NDA Submission
Based on the feedback from the FDA, the Company’s regulatory data package would be sufficient for the submission of an sNDA for AXS-05 for the treatment of Alzheimer’s disease agitation. Axsome ...