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FDA Updates

Latest News

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
FDA approval stamp
News
07/10/2025
Maria Mantas
The US Food and Drug Administration (FDA) has approved a label update for donanemab-azbt (Kisunla), Eli Lilly and Company’s monthly intravenous amyloid-targeting therapy for adults with early symptomatic Alzheimer disease (AD).
The US Food and Drug Administration (FDA) has approved a label update for donanemab-azbt (Kisunla), Eli Lilly and Company’s monthly intravenous amyloid-targeting therapy for adults with early symptomatic Alzheimer disease (AD).
The US Food and Drug...
07/10/2025
Psych Congress Network
FDA approval stamp
News
05/19/2025
Meagan Thistle
The FDA has approved the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test, the first blood-based diagnostic tool intended to aid in evaluating Alzheimer disease (AD) pathology.
The FDA has approved the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test, the first blood-based diagnostic tool intended to aid in evaluating Alzheimer disease (AD) pathology.
The FDA has approved the...
05/19/2025
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
A man with depression holds his head in his hands
Research Summary
06/22/2026
Brionna Mendoza
Navacaprant, a kappa opioid receptor antagonist for major depressive disorder treatment, failed to show statistically significant efficacy in two phase 3 trials.
Navacaprant, a kappa opioid receptor antagonist for major depressive disorder treatment, failed to show statistically significant efficacy in two phase 3 trials.
Navacaprant, a kappa opioid...
06/22/2026
Psych Congress Network
a man surrounded by alcohol and other substances on a table
News
06/18/2026
Maria Mantas
Evaluating reduced stimulant use rather than complete abstinence outcomes in patients with stimulant use disorder could provide additional insight into treatment efficacy.
Evaluating reduced stimulant use rather than complete abstinence outcomes in patients with stimulant use disorder could provide additional insight into treatment efficacy.
Evaluating reduced stimulant use...
06/18/2026
Psych Congress Network
Viloxazine MOA Study image
News
06/11/2026
New research further characterizes viloxazine’s pharmacologic profile, supporting a multimodal mechanism involving norepinephrine transporters and serotonin receptors.
New research further characterizes viloxazine’s pharmacologic profile, supporting a multimodal mechanism involving norepinephrine transporters and serotonin receptors.
New research further...
06/11/2026
Psych Congress Network
Weight scale and tape measure
News
06/11/2026
A retrospective cohort study examined the association between pediatric ADHD, methylphenidate exposure, and adult BMI and height outcomes. The findings suggest that ADHD—particularly when treated with methylphenidate—may be associated with...
A retrospective cohort study examined the association between pediatric ADHD, methylphenidate exposure, and adult BMI and height outcomes. The findings suggest that ADHD—particularly when treated with methylphenidate—may be associated with...
A retrospective cohort study...
06/11/2026
Psych Congress Network
a woman scrolls on her phone while laying in bed
News
05/28/2026
Maria Mantas
A recent target trial emulation found no evidence of a causal relationship between frequent AI use and increased depressive symptoms among adults.
A recent target trial emulation found no evidence of a causal relationship between frequent AI use and increased depressive symptoms among adults.
A recent target trial emulation...
05/28/2026
Psych Congress Network
A clinician in the lab pulls a psilocybin mushroom from a bag using tweezers major depressive disorder mdd treatment
News
05/19/2026
Brionna Mendoza
A single dose of psilocybin was associated with a significant reduction in depressive symptoms within 2 days of administration in patients with major depressive disorder (MDD), according to randomized control trial results.
A single dose of psilocybin was associated with a significant reduction in depressive symptoms within 2 days of administration in patients with major depressive disorder (MDD), according to randomized control trial results.
A single dose of psilocybin was...
05/19/2026
Psych Congress Network
injection for schizophrenia treatment
News
05/14/2026
Maria Mantas
Once-monthly aripiprazole 400 mg (AOM 400) demonstrated a favorable risk-benefit profile as an acute and long-term maintenance treatment in patients with schizophrenia.
Once-monthly aripiprazole 400 mg (AOM 400) demonstrated a favorable risk-benefit profile as an acute and long-term maintenance treatment in patients with schizophrenia.
Once-monthly aripiprazole 400 mg...
05/14/2026
Psych Congress Network
A man with depression holds his head in his hands
News
05/12/2026
Brionna Mendoza
A new systematic review and network meta-analysis published in JAMA Psychiatry evaluated the comparative efficacy and acceptability of the 5 FDA-approved atypical antipsychotics used as adjunctive therapy for major depressive disorder (MDD).
A new systematic review and network meta-analysis published in JAMA Psychiatry evaluated the comparative efficacy and acceptability of the 5 FDA-approved atypical antipsychotics used as adjunctive therapy for major depressive disorder (MDD).
A new systematic review and...
05/12/2026
Psych Congress Network
A boy eating junk food while using a laptop computer
News
05/12/2026
Recent findings point to a possible link between ADHD and higher intake of ultra-processed foods.
Recent findings point to a possible link between ADHD and higher intake of ultra-processed foods.
Recent findings point to a...
05/12/2026
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
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
Jain, Mattingly, and Raison
Rapid Reaction
05/12/2026
Rakesh Jain, MD, MPH, RD; Greg Mattingly, MD; Charles L. Raison, MD
Psych Congress faculty members share their expert perspectives on the HHS deprescribing action plan and Dear Colleague letter.
Psych Congress faculty members share their expert perspectives on the HHS deprescribing action plan and Dear Colleague letter.
Psych Congress faculty members...
05/12/2026
Psych Congress Network
Craig Chepke, MD, DFAPA
Videos
05/12/2026
Craig Chepke, MD, DFAPA
In this video, Craig Chepke, MD, DFAPA, Chief Medical Officer, Psych Congress, discusses the pitfalls of evaluating tardive dyskinesia (TD) treatment progress by an Abnormal Involuntary Movement Scale (AIMS) score alone.
In this video, Craig Chepke, MD, DFAPA, Chief Medical Officer, Psych Congress, discusses the pitfalls of evaluating tardive dyskinesia (TD) treatment progress by an Abnormal Involuntary Movement Scale (AIMS) score alone.
In this video, Craig Chepke, MD,...
05/12/2026
Psych Congress Network
Craig Chepke, MD, DFAPA
Videos
05/12/2026
Craig Chepke, MD, DFAPA
In this video, Craig Chepke, MD, DFAPA, Chief Medical Officer, Psych Congress, discusses the pitfalls of evaluating tardive dyskinesia (TD) treatment progress by an Abnormal Involuntary Movement Scale (AIMS) score alone.
In this video, Craig Chepke, MD, DFAPA, Chief Medical Officer, Psych Congress, discusses the pitfalls of evaluating tardive dyskinesia (TD) treatment progress by an Abnormal Involuntary Movement Scale (AIMS) score alone.
In this video, Craig Chepke, MD,...
05/12/2026
Psych Congress Network
Brooke Kempf, PMHNP-BC
Videos
04/16/2026
Brooke Kempf, MSN, PMHNP-BC
Psych Congress Steering Committee member Brooke Kempf, PMHNP-BC, offers clinicians a practical framework for differentiating overlapping symptoms, anxious distress, and mixed features in MDD.
Psych Congress Steering Committee member Brooke Kempf, PMHNP-BC, offers clinicians a practical framework for differentiating overlapping symptoms, anxious distress, and mixed features in MDD.
Psych Congress Steering...
04/16/2026
Psych Congress Network
Philip Gehrman, PhD, CBSM, FAASM
Videos
04/08/2026
Philip Gehrman, PhD
Psych Congress Steering Committee Partner Philip Gehrman, PhD, CBSM, FAASM, discusses how targeting sleep may improve outcomes for patients with co-occurring sleep and psychiatric disorders.
Psych Congress Steering Committee Partner Philip Gehrman, PhD, CBSM, FAASM, discusses how targeting sleep may improve outcomes for patients with co-occurring sleep and psychiatric disorders.
Psych Congress Steering...
04/08/2026
Psych Congress Network
Timothy Wilens, MD
Videos
04/01/2026
Timothy Wilens, MD
Timothy Wilens, MD, explores common patterns of attention-deficit/hyperactivity disorder (ADHD) psychiatric comorbidities throughout different developmental stages.
Timothy Wilens, MD, explores common patterns of attention-deficit/hyperactivity disorder (ADHD) psychiatric comorbidities throughout different developmental stages.
Timothy Wilens, MD, explores...
04/01/2026
Psych Congress Network
Brittany Albright MD, MPH
Videos
03/13/2026
Brittany Albright, MD, MPH
In this insightful discussion, Brittany Albright, MD, MPH, Co-Chair, Psych Congress Elevate, offers a comprehensive overview of the role that deprescribing plays in effective psychiatric care.
In this insightful discussion, Brittany Albright, MD, MPH, Co-Chair, Psych Congress Elevate, offers a comprehensive overview of the role that deprescribing plays in effective psychiatric care.
In this insightful discussion,...
03/13/2026
Psych Congress Network
Chelsie Monroe, APN, PMHNP-BC
Videos
03/09/2026
Chelsie Monroe, PMHNP-BC, APN
Chelsie Monroe, APN, PMHNP-BC, discusses practical screening strategies, including the use of the Epworth Sleepiness Scale, the importance of collaboration with sleep specialists, and the clinical relevance of the orexin system.
Chelsie Monroe, APN, PMHNP-BC, discusses practical screening strategies, including the use of the Epworth Sleepiness Scale, the importance of collaboration with sleep specialists, and the clinical relevance of the orexin system.
Chelsie Monroe, APN, PMHNP-BC,...
03/09/2026
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
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
A boy eating junk food while using a laptop computer
Quiz
05/12/2026
How well do you understand the emerging evidence linking ultra-processed foods and ADHD? Assess your knowledge with this brief quiz.
How well do you understand the emerging evidence linking ultra-processed foods and ADHD? Assess your knowledge with this brief quiz.
How well do you understand the...
05/12/2026
Psych Congress Network
Nishi Bhopal, MD
Quiz
05/06/2026
Maria Mantas
What is the recommended first step to confirm whether a patient is experiencing excessive daytime sleepiness? Take this quick quiz to test your knowledge!
What is the recommended first step to confirm whether a patient is experiencing excessive daytime sleepiness? Take this quick quiz to test your knowledge!
What is the recommended first...
05/06/2026
Psych Congress Network
a printed test, pencil, and clock on a desk
Quiz
04/30/2026
Maria Mantas
What was the association between all-cause mortality risk and bipolar II disorder? Test your knowledge with this quiz!
What was the association between all-cause mortality risk and bipolar II disorder? Test your knowledge with this quiz!
What was the association between...
04/30/2026
Psych Congress Network
an illustrated laptop screen displaying a quiz
Quiz
04/27/2026
Maria Mantas
Can you recall how the use of pharmacogenomic testing impacted treatment outcomes in major depressive disorder (MDD)?
Can you recall how the use of pharmacogenomic testing impacted treatment outcomes in major depressive disorder (MDD)?
Can you recall how the use of...
04/27/2026
Psych Congress Network