The US Food and Drug Administration (FDA) has approved scPharmaceuticals’ supplemental new drug application (sNDA) for ...

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 (NASDAQ:AXSM) said on Monday that in the FDA meeting minutes, the agency has supported a supplemental NDA ...

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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This press release contains forward-looking statements about planned presentations at a scientific conference and a potential sNDA submission for Afrezza that involves risks and uncertainties.

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 ...

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 ...