“We are pleased with the pre-NDA meeting feedback we received from the FDA, which confirmed the studies and data to be presented in our planned sNDA submission of AXS-05 for the treatment of ...

Acceptance of the final sNDA will be subject to the FDA’s review of the complete filing. AXS-05 was granted Breakthrough Therapy designation for the treatment of Alzheimer’s disease agitation in June ...

supporting a supplemental NDA (sNDA) submission for AXS-05 in Alzheimer’s disease agitation. AXS-05 (dextromethorphan-bupropion) is a novel, oral, investigational NMDA receptor antagonist ...

Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization ...

The Company expects to submit a supplemental NDA (sNDA) filing for revumenib in R/R mNPM1 AML in the second quarter of 2025, followed by a potential FDA approval around year-end 2025. The Company ...

VUITY, an FDA-approved eye drop for presbyopia, has significant market potential given the growing aging population. With an estimated 128 million Americans affected by presbyopia, VUITY offers ...

Axsome Therapeutics (NASDAQ:AXSM) said on Monday that in the FDA meeting minutes, the agency has supported a supplemental NDA submission ... format of the planned sNDA submission including the ...