FDA: Inclusion complex of a GRAS guest and a GRAS host is also GRAS
At first glance, it may seem straightforward to assume that an inclusion complex formed between a GRAS-listed guest molecule and
Tag: FDA
FDA grants approval to Axsome Therapeutics’ migraine medication containing Betadex Sulfobutylether Sodium
The U.S. Food and Drug Administration has approved Axsome Therapeutics’ new migraine treatment tablet on 30 January 2025 [1]. Marketed
Bridion® injection now approved for patients of all ages
Merck Sharp & Dohme LLC has submitted supplemental new drug application which was received on June 12, 2024 by FDA
Axsome Therapeutics’ betadex sulfobutylether sodium containing composition: FDA Acceptance of NDA Resubmission
Axsome Therapeutics, Inc., an U.S.-based biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS)
FDA Approves Veklury® (Remdesivir) for the Treatment of Non-Hospitalized Patients at High Risk for COVID-19 Disease Progression
— Approval Based on Phase 3 Data Showing Veklury Significantly Reduced Risk of Hospitalization By 87% Compared with Placebo —
Virtual Public Meeting: Endpoint Considerations to Facilitate Drug Development for Niemann-Pick Type C (NPC)
On January 24-25, 2022, the FDA and Duke-Margolis Center for Health Policy will host a virtual publicworkshop on endpoint considerations
Cyclo Therapeutics Receives IND Clearance from the U.S. FDA to Advance its Phase 2 Study of Trappsol® Cyclo™ for the Treatment of Alzheimer’s Disease
Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company dedicated to developing life-changing medicines through
Cyclo Therapeutics Submits IND Application to U.S. FDA to Advance Trappsol® Cyclo™ in Phase 2 Study for Treatment of Alzheimer’s Disease
Cyclo Therapeutics, Inc., a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and
Marinus Announces FDA Acceptance for Filing and Priority Review of NDA for SBECD-enabled Ganaxolone in CDKL5 Deficiency Disorder
Marinus Pharmaceuticals, Inc. , a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, announced that
Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-07 for the Acute Treatment of Migraine
Axsome Therapeutics, Inc., a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced