The US Food and Drug Administration (FDA) has approved scPharmaceuticals’ supplemental new drug application (sNDA) for ...
Axsome Therapeutics (NASDAQ:AXSM) said on Monday that in the FDA meeting minutes, the agency has supported a supplemental NDA ...
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.
Axsome Therapeutics (AXSM) has received formal pre-New Drug Application meeting minutes from the U.S. Food and Drug Administration supporting a ...
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DALLAS--(BUSINESS WIRE)--Sonida Senior Living, Inc. (“Sonida” or the “Company”) (NYSE: SNDA), a leading owner, operator and investor in communities and services for seniors, today announced that it ...
London South East prides itself on its community spirit, and in order to keep the chat section problem free, we ask all members to follow these simple rules. In these rules, we refer to ourselves ...
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 ...