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Tag: FDA

January 25, 2022 Drug delivery / Pharma applications

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 —

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January 10, 2022 CD as API / Events / Pharma applications

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

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December 7, 2021 CD as API / CD derivatives / Pharma applications

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

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November 18, 2021 CD as API / CD derivatives / Pharma applications

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

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September 21, 2021 Drug delivery / Pharma applications

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

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September 15, 2021 Drug delivery / Pharma applications

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

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April 29, 2021 CD as API / CD derivatives / Pharma applications

Cyclo Therapeutics Announces Design of Pivotal Phase 3 Study Evaluating Trappsol® Cyclo™ in Niemann-Pick Type C1

Cyclo Therapeutics, Inc., a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and

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April 22, 2021 CD as API / CD derivatives / Pharma applications

Cyclo Therapeutics to Proceed with IND Filing for Phase 2 Trial Using Intravenous Trappsol® Cyclo™ in Alzheimer’s Disease

Cyclo Therapeutics, Inc., a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and

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January 14, 2021 Drug delivery / Pharma applications

Marinus Pharmaceuticals Receives Positive Response from FDA on Sufficiency of One Phase 3 Clinical Trial for Filing of New Drug Application (NDA) for the Use of SBECD-enabled Ganaxolone in CDKL5 Deficiency Disorder (CDD)

Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders,

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November 9, 2020 Drug delivery / Pharma applications

Sedor Pharmaceuticals Receives FDA Approval for SESQUIENT™ (SBECD-enabled fosphenytoin)

Ligand Pharmaceuticals Incorporated announced that its partner Sedor Pharmaceuticals, LLC has received approval from the U.S. Food and Drug Administration

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