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FDA Updates

Latest News

FDA building
FDA Approval
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
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
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
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
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
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
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
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
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
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
US FDA sign
News
08/06/2026
Brionna Mendoza
The US FDA has approved oveporexton (ORZEYFUL), a first-in-class orexin treatment for narcolepsy type 1 (NT1) in adults.
The US FDA has approved oveporexton (ORZEYFUL), a first-in-class orexin treatment for narcolepsy type 1 (NT1) in adults.
The US FDA has approved...
08/06/2026
Psych Congress Network
FDA building
FDA Approval
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
illustration of a brain
Research Summary
07/21/2026
Maria Mantas
Patients with TRD receiving repeated, low-dose oral esketamine did not experience greater increases in serum BDNF than those receiving placebo, according to study findings.
Patients with TRD receiving repeated, low-dose oral esketamine did not experience greater increases in serum BDNF than those receiving placebo, according to study findings.
Patients with TRD receiving...
07/21/2026
Psych Congress Network
FDA approval stamp
FDA Alerts
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
Rakesh Jain, MD, MPH
Rapid Reaction
07/16/2026
Rakesh Jain, MD, MPH, RD; Maria Mantas
Rakesh Jain, MD, MPH, responds to news that Eli Lilly and Company plans to acquire AtaiBeckley Inc, expanding its presence in the emerging field of psychedelic-based treatments for depression and other psychiatric conditions.
Rakesh Jain, MD, MPH, responds to news that Eli Lilly and Company plans to acquire AtaiBeckley Inc, expanding its presence in the emerging field of psychedelic-based treatments for depression and other psychiatric conditions.
Rakesh Jain, MD, MPH, responds...
07/16/2026
Psych Congress Network
a stethoscope, pills, and brain
Research Summary
07/16/2026
Maria Mantas
Patients with MDD and favorable biobehavioral markers for sertraline and/or bupropion experienced higher antidepressant response rates than those with negative markers for both drugs.
Patients with MDD and favorable biobehavioral markers for sertraline and/or bupropion experienced higher antidepressant response rates than those with negative markers for both drugs.
Patients with MDD and favorable...
07/16/2026
Psych Congress Network
an illustration of a man sitting on the ground holding his head with his profile and brain in the background
Research Summary
07/10/2026
Brionna Mendoza
A randomized clinical trial found that 10 once-daily sessions of iTBS produced short-term improvement compared to sham in clinician-rated depressive symptoms among adults with recurrent major depressive disorder (MDD).
A randomized clinical trial found that 10 once-daily sessions of iTBS produced short-term improvement compared to sham in clinician-rated depressive symptoms among adults with recurrent major depressive disorder (MDD).
A randomized clinical trial...
07/10/2026
Psych Congress Network
pills spilling out of a tipped over pill bottle
News
07/01/2026
Maria Mantas
Sodium-glucose cotransporter 2 (SGLT2) inhibitor use was associated with a lower risk of incident all-cause dementia among older US veterans with mood and psychotic disorders. 
Sodium-glucose cotransporter 2 (SGLT2) inhibitor use was associated with a lower risk of incident all-cause dementia among older US veterans with mood and psychotic disorders. 
Sodium-glucose cotransporter 2...
07/01/2026
Psych Congress Network
A patient sits across from a doctor who has a clipboard and is filling out a phone
Research Summary
06/29/2026
Brionna Mendoza
DT120, a proprietary formulation of lysergide (LSD) for treatment of MDD, met both primary and key secondary endpoints in the phase 3 Emerge study.
DT120, a proprietary formulation of lysergide (LSD) for treatment of MDD, met both primary and key secondary endpoints in the phase 3 Emerge study.
DT120, a proprietary formulation...
06/29/2026
Psych Congress Network
a young woman lies awake in bed
News
06/25/2026
Maria Mantas
A 3-year longitudinal study found that insomnia, excessive daytime sleepiness (EDS), and their co-occurrence were associated with increased risk of depression. 
A 3-year longitudinal study found that insomnia, excessive daytime sleepiness (EDS), and their co-occurrence were associated with increased risk of depression. 
A 3-year longitudinal study...
06/25/2026
Psych Congress Network

Exclusives

andrew penn
Videos
07/01/2024
Andrew Penn, RN, MS, NP, CNS, APRN-BC
Andrew Penn, MS, PMHNP, discusses the recent vote by the FDA's advisory committee (PDAC) against an MDMA-based therapy for the treatment of PTSD in adults and sheds light on what this means for the future of PTSD treatment.
Andrew Penn, MS, PMHNP, discusses the recent vote by the FDA's advisory committee (PDAC) against an MDMA-based therapy for the treatment of PTSD in adults and sheds light on what this means for the future of PTSD treatment.
Andrew Penn, MS, PMHNP,...
07/01/2024
Psych Congress Network
andrew penn
Videos
06/21/2024
Andrew Penn, MS, PMHNP, discusses the recent vote by the FDA's advisory committee (PDAC) against an MDMA-based therapy for the treatment of PTSD in adults and sheds light on what this means for the future of PTSD treatment.
Andrew Penn, MS, PMHNP, discusses the recent vote by the FDA's advisory committee (PDAC) against an MDMA-based therapy for the treatment of PTSD in adults and sheds light on what this means for the future of PTSD treatment.
Andrew Penn, MS, PMHNP,...
06/21/2024
Psych Congress Network
James Greenblatt, MD
Videos
08/05/2026
James Greenblatt, MD
James Greenblatt, MD, discusses where lifestyle, nutritional, and functional medicine strategies may help address gaps in conventional psychiatric care.
James Greenblatt, MD, discusses where lifestyle, nutritional, and functional medicine strategies may help address gaps in conventional psychiatric care.
James Greenblatt, MD, discusses...
08/05/2026
Psych Congress Network
Craig Chepke and Kevin Williams
Major Depressive Disorder Insights
07/28/2026
Craig Chepke, MD, DFAPA; Kevin Williams, MS, MPAS, PA-C
Craig Chepke, MD, DFAPA, and Kevin Williams, MS, MPAS, PA-C, discuss how clinicians can align major depressive disorder (MDD) treatment goals with patients’ lived experience of anhedonia.
Craig Chepke, MD, DFAPA, and Kevin Williams, MS, MPAS, PA-C, discuss how clinicians can align major depressive disorder (MDD) treatment goals with patients’ lived experience of anhedonia.
Craig Chepke, MD, DFAPA, and...
07/28/2026
Psych Congress Network
Arwen Podesta, MD, DFAPA, DFASAM
Videos
07/24/2026
Arwen Podesta, MD
In this conversation with PCN, Arwen Podesta, MD, DFAPA, DFASAM, discusses how medication-assisted therapy (MAT) may improve patient outcomes in alcohol use disorder (AUD).
In this conversation with PCN, Arwen Podesta, MD, DFAPA, DFASAM, discusses how medication-assisted therapy (MAT) may improve patient outcomes in alcohol use disorder (AUD).
In this conversation with PCN,...
07/24/2026
Psych Congress Network
Jill Harkavy-Friedman, PhD
Videos
07/20/2026
Jill Harkavy-Friedman, PhD
Jill Harkavy-Friedman, PhD, walks clinicians through what a comprehensive assessment of suicide risk looks like in clinical practice.
Jill Harkavy-Friedman, PhD, walks clinicians through what a comprehensive assessment of suicide risk looks like in clinical practice.
Jill Harkavy-Friedman, PhD,...
07/20/2026
Psych Congress Network
Rakesh Jain, MD, MPH
Videos
07/16/2026
Rakesh Jain, MD, MPH, RD
Rakesh Jain, MD, MPH, Co-Chair, Psych Congress discusses why sleep complaints in psychiatric practice warrant direct evaluation rather than dismissal as secondary symptoms.
Rakesh Jain, MD, MPH, Co-Chair, Psych Congress discusses why sleep complaints in psychiatric practice warrant direct evaluation rather than dismissal as secondary symptoms.
Rakesh Jain, MD, MPH, Co-Chair,...
07/16/2026
Psych Congress Network
Kristian Dambrino, DNP, PMHNP-BC
Videos
07/07/2026
Kristian Dambrino, DNP, PMHNP, MSN
Psych Congress Elevate Co-Chair Kristian Dambrino, DNP, PMHNP-BC, discusses practical considerations for pinpointing whether and when to begin targeted treatment for tardive dyskinesia (TD).
Psych Congress Elevate Co-Chair Kristian Dambrino, DNP, PMHNP-BC, discusses practical considerations for pinpointing whether and when to begin targeted treatment for tardive dyskinesia (TD).
Psych Congress Elevate Co-Chair...
07/07/2026
Psych Congress Network
Kristian Dambrino, DNP, PMHNP-BC
Videos
07/07/2026
Kristian Dambrino, DNP, PMHNP, MSN
Psych Congress Elevate Co-Chair Kristian Dambrino, DNP, PMHNP-BC, discusses practical considerations for pinpointing whether and when to begin targeted treatment for tardive dyskinesia (TD).
Psych Congress Elevate Co-Chair Kristian Dambrino, DNP, PMHNP-BC, discusses practical considerations for pinpointing whether and when to begin targeted treatment for tardive dyskinesia (TD).
Psych Congress Elevate Co-Chair...
07/07/2026
Psych Congress Network
Craig Chepke and Kevin Williams
Major Depressive Disorder Insights
07/07/2026
Craig Chepke, MD, DFAPA; Kevin Williams, MS, MPAS, PA-C
Craig Chepke, MD, DFAPA, and Kevin Williams, MS, MPAS, PA-C, discuss how busy outpatient clinicians can effectively screen for anhedonia in major depressive disorder.
Craig Chepke, MD, DFAPA, and Kevin Williams, MS, MPAS, PA-C, discuss how busy outpatient clinicians can effectively screen for anhedonia in major depressive disorder.
Craig Chepke, MD, DFAPA, and...
07/07/2026
Psych Congress Network
B. Nilaja Green, PhD
Q&As
06/05/2026
B. Nilaja Green, PhD
B. Nilaja Green, PhD, reviews how psychiatric providers and psychotherapists can ensure they are aligned on patient treatment progress and goals.
B. Nilaja Green, PhD, reviews how psychiatric providers and psychotherapists can ensure they are aligned on patient treatment progress and goals.
B. Nilaja Green, PhD, reviews...
06/05/2026
Psych Congress Network
Veronica Ridpath, DO
Q&A
06/05/2026
Veronica Ridpath, DO
Veronica Ridpath, DO. discusses key considerations for diagnosing and supporting patients with autism spectrum disorder (ASD) in psychiatric practice.
Veronica Ridpath, DO. discusses key considerations for diagnosing and supporting patients with autism spectrum disorder (ASD) in psychiatric practice.
Veronica Ridpath, DO. discusses...
06/05/2026
Psych Congress Network

Refresher Quizzes

FDA
Quiz
04/25/2024
Do you remember this FDA update?
Do you remember this FDA update?
Do you remember this FDA update?
04/25/2024
Psych Congress Network
Chelsie Monroe Expert Insights Quiz
Expert Insights Quiz
08/03/2026
Maria Mantas
What key characteristics can help clinicians differentiate fatigue from excessive daytime sleepiness in clinical practice?
What key characteristics can help clinicians differentiate fatigue from excessive daytime sleepiness in clinical practice?
What key characteristics can...
08/03/2026
Psych Congress Network
a printed test, pencil, and clock on a desk
Quiz
07/23/2026
Maria Mantas
Can you recall what the APA guideline recommends? Test yourself with this quick quiz!
Can you recall what the APA guideline recommends? Test yourself with this quick quiz!
Can you recall what the APA...
07/23/2026
Psych Congress Network
Craig Chepke, MD, DFAPA
Major Depressive Disorder Insights Quiz
07/22/2026
Maria Mantas
Why should clinicians think of anhedonia in major depressive disorder (MDD) as more than simply a loss of pleasure? Test your knowledge with this quiz!
Why should clinicians think of anhedonia in major depressive disorder (MDD) as more than simply a loss of pleasure? Test your knowledge with this quiz!
Why should clinicians think of...
07/22/2026
Psych Congress Network
an illustrated laptop screen displaying a quiz
Quiz
07/13/2026
Maria Mantas
Can you recall which symptom of MDD patients most wanted to see improved by treatment? Take the quiz!
Can you recall which symptom of MDD patients most wanted to see improved by treatment? Take the quiz!
Can you recall which symptom of...
07/13/2026
Psych Congress Network
Viloxazine MOA Study image
Quiz
06/12/2026
New research suggests that viloxazine has a multimodal mechanism of action. Test your understanding with this short quiz.
New research suggests that viloxazine has a multimodal mechanism of action. Test your understanding with this short quiz.
New research suggests that...
06/12/2026
Psych Congress Network
Weight scale and tape measure
Quiz
06/12/2026
How well do you understand the relationship between pediatric attention-deficit/hyperactivity disorder, methylphenidate use in childhood, and growth outcomes in adulthood? Test your knowledge with this short, multiple-choice quiz.
How well do you understand the relationship between pediatric attention-deficit/hyperactivity disorder, methylphenidate use in childhood, and growth outcomes in adulthood? Test your knowledge with this short, multiple-choice quiz.
How well do you understand the...
06/12/2026
Psych Congress Network
Pop quiz written on a blackboard with white chalk
Quiz
06/11/2026
Brionna Mendoza
Test your knowledge of recent research with this quiz!
Test your knowledge of recent research with this quiz!
Test your knowledge of recent...
06/11/2026
Psych Congress Network
Desiree Matthews, PMHNP-BC
Quiz
06/10/2026
Maria Mantas
Why does Desiree Matthews, PMHNP-BC, recommend careful consideration of metabolic pathways when selecting a vesicular monoamine transporter 2 (VMAT2) inhibitor for tardive dyskinesia (TD) treatment?
Why does Desiree Matthews, PMHNP-BC, recommend careful consideration of metabolic pathways when selecting a vesicular monoamine transporter 2 (VMAT2) inhibitor for tardive dyskinesia (TD) treatment?
Why does Desiree Matthews,...
06/10/2026
Psych Congress Network
Desiree Matthews, PMHNP-BC
Quiz
06/10/2026
Maria Mantas
Why does Desiree Matthews, PMHNP-BC, recommend careful consideration of metabolic pathways when selecting a vesicular monoamine transporter 2 (VMAT2) inhibitor for tardive dyskinesia (TD) treatment?
Why does Desiree Matthews, PMHNP-BC, recommend careful consideration of metabolic pathways when selecting a vesicular monoamine transporter 2 (VMAT2) inhibitor for tardive dyskinesia (TD) treatment?
Why does Desiree Matthews,...
06/10/2026
Psych Congress Network
Girl in a classroom staring off into the distance
Quiz
05/12/2026
Differences in ADHD presentation between males and females may affect diagnosis and outcomes. Evaluate your understanding of key clinical distinctions with this short quiz.
Differences in ADHD presentation between males and females may affect diagnosis and outcomes. Evaluate your understanding of key clinical distinctions with this short quiz.
Differences in ADHD presentation...
05/12/2026
Psych Congress Network