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FDA Updates News

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FDA Approval
FDA Approves Centanafadine for Pediatric and Adult ADHD
07/27/2026
Maria Mantas
The US Food and Drug Administration (FDA) has approved centanafadine (SIMTRIYO), a norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI), for the treatment of attention-deficit/hyperactivity disorder (ADHD).
The US Food and Drug Administration (FDA) has approved centanafadine (SIMTRIYO), a norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI), for the treatment of attention-deficit/hyperactivity disorder (ADHD).
The US Food and Drug...
07/27/2026
Psych Congress Network
FDA approval stamp
FDA Alerts
FDA Accepts NDA for AXS-12 in Cataplexy Associated With Narcolepsy
07/16/2026
Maria Mantas
The US Food and Drug Administration (FDA) accepted Axsome Therapeutics’ New Drug Application (NDA) for AXS-12 (reboxetine) for cataplexy in narcolepsy.
The US Food and Drug Administration (FDA) accepted Axsome Therapeutics’ New Drug Application (NDA) for AXS-12 (reboxetine) for cataplexy in narcolepsy.
The US Food and Drug...
07/16/2026
Psych Congress Network
Food and Drug Administration building
News
FDA Approves Milsaperidone for Bipolar I and Schizophrenia in Adults
02/24/2026
Maria Mantas
The FDA has approved milsaperidone for the treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
The FDA has approved milsaperidone for the treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
The FDA has approved...
02/24/2026
Psych Congress Network
US FDA building
News
FDA Requests Removal of Suicide Risk Warnings From GLP-1 RA Labels
01/14/2026
Maria Mantas
The US Food and Drug Administration (FDA) has requested the removal of information regarding the risk of suicidal ideation and behaviors (SI/B) from the labeling of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications.
The US Food and Drug Administration (FDA) has requested the removal of information regarding the risk of suicidal ideation and behaviors (SI/B) from the labeling of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications.
The US Food and Drug...
01/14/2026
Psych Congress Network
FDA building
News
FDA Approves At-Home Neuromodulation Therapy Device for Major Depression
01/12/2026
Maria Mantas
The US Food and Drug Administration has approved Proliv™Rx, a novel at-home neuromodulation therapy as adjunctive treatment for adults with major depressive disorder (MDD).
The US Food and Drug Administration has approved Proliv™Rx, a novel at-home neuromodulation therapy as adjunctive treatment for adults with major depressive disorder (MDD).
The US Food and Drug...
01/12/2026
Psych Congress Network
FDA approval stamp
News
FDA Approves First At-Home tDCS Treatment for Major Depressive Disorder
12/16/2025
Maria Mantas
The US Food and Drug Administration (FDA) has approved the first at-home transcranial direct current stimulation (tDCS) device for the treatment of moderate to severe major depressive disorder (MDD).
The US Food and Drug Administration (FDA) has approved the first at-home transcranial direct current stimulation (tDCS) device for the treatment of moderate to severe major depressive disorder (MDD).
The US Food and Drug...
12/16/2025
Psych Congress Network
FDA approval stamp
News
FDA Approves Lumateperone Indication for Major Depressive Disorder
11/07/2025
Maria Mantas
The US Food and Drug Administration (FDA) has approved lumateperone (CAPLYTA®) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults.
The US Food and Drug Administration (FDA) has approved lumateperone (CAPLYTA®) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults.
The US Food and Drug...
11/07/2025
Psych Congress Network
US FDA sign
News
FDA OKs Once Monthly Subcutaneous Risperidone for Bipolar I Disorder
10/20/2025
Brionna Mendoza
The US Food and Drug Administration (FDA) has approved risperidone (Uzedy) as a once-monthly extended-release injectable suspension for the treatment of bipolar I disorder (BD-I).
The US Food and Drug Administration (FDA) has approved risperidone (Uzedy) as a once-monthly extended-release injectable suspension for the treatment of bipolar I disorder (BD-I).
The US Food and Drug...
10/20/2025
Psych Congress Network
fda building sign
News
FDA Approves TMS Device for Major Depressive Disorder in Adolescents
09/11/2025
Brionna Mendoza
The US Food and Drug Administration (FDA) approved on Wednesday the Apollo Transcranial Magnetic Stimulation (TMS) Therapy devices for the adjunctive treatment of major depressive disorder (MDD) in adolescents.
The US Food and Drug Administration (FDA) approved on Wednesday the Apollo Transcranial Magnetic Stimulation (TMS) Therapy devices for the adjunctive treatment of major depressive disorder (MDD) in adolescents.
The US Food and Drug...
09/11/2025
Psych Congress Network
FDA building
News
FDA Advisory Committee Votes Against Brexpiprazole Indication for Treatment of PTSD Following Efficacy Concerns
07/21/2025
Maria Mantas
The US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted not to recommend the use of brexpiprazole in combination with sertraline for the treatment of posttraumatic stress disorder (PTSD).  
The US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted not to recommend the use of brexpiprazole in combination with sertraline for the treatment of posttraumatic stress disorder (PTSD).  
The US Food and Drug...
07/21/2025
Psych Congress Network

NEW FROM THE NP INSTITUTE ONLINE LEARNING HUB

andrew and julie
Rapid Refresh
Navigating Bipolar Disorder Treatment: Exploring the Role of Second-Generation Antipsychotics
04/11/2024

Featuring Andrew Penn, MS, PMHNP, and Julie Carbray, PhD, FPMHNP-BC, PMHCNS-BC, APRN

Featuring Andrew Penn, MS, PMHNP...
Andrew Penn, MS, PMHNP, and Julie Carbray, PhD, FPMHNP-BC, PMHCNS-BC, APRN, explore the nuanced role of second-generation antipsychotics in bipolar disorder treatment. They discuss the complexities of managing mania and depression phases and...
Andrew Penn, MS, PMHNP, and Julie Carbray, PhD, FPMHNP-BC, PMHCNS-BC, APRN, explore the nuanced role of second-generation antipsychotics in bipolar disorder treatment. They discuss the complexities of managing mania and depression phases and...
Andrew Penn, MS, PMHNP, and...
04/11/2024
Psych Congress NP Institute
Amber Hoberg
Rapid Refresh
Long-Acting Injectables for Adolescents With Schizophrenia and Schizoaffective Disorder
04/10/2024
Amber Hoberg, MSN, APRN, PMHNP-BC
Amber Hoberg, PMHNP-BC, navigates the complexities of adolescent psychosis treatment, exploring the potential benefits and considerations of LAIs for schizophrenia and schizoaffective disorder, while emphasizing evidence-based practice for...
Amber Hoberg, PMHNP-BC, navigates the complexities of adolescent psychosis treatment, exploring the potential benefits and considerations of LAIs for schizophrenia and schizoaffective disorder, while emphasizing evidence-based practice for...
Amber Hoberg, PMHNP-BC,...
04/10/2024
Psych Congress NP Institute
Hoberg and Matthews
Clinical Insights
Tolerability Testing in Long-Acting Injectable Prescriptions
04/03/2024
Desiree Matthews, PHMNP-BC; Amber Hoberg, MSN, APRN, PMHNP-BC
Do clinicians need to test for tolerability before prescribing a long-acting injectable (LAI)? Desiree Matthews, PMHNP-BC, and Amber Hoberg, MSN, APRN, PMHNP-BC, offer their clinical insight.
Do clinicians need to test for tolerability before prescribing a long-acting injectable (LAI)? Desiree Matthews, PMHNP-BC, and Amber Hoberg, MSN, APRN, PMHNP-BC, offer their clinical insight.
Do clinicians need to test for...
04/03/2024
Psych Congress NP Institute

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