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FDA Updates

Latest News

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
FDA building
News
01/28/2025
Meagan Thistle
The FDA has approved a supplemental biologics license application for lecanemab-irmb (Leqembi, Eisai Co., Ltd.; Biogen Inc.), an intravenous treatment (IV) for early Alzheimer disease (AD).
The FDA has approved a supplemental biologics license application for lecanemab-irmb (Leqembi, Eisai Co., Ltd.; Biogen Inc.), an intravenous treatment (IV) for early Alzheimer disease (AD).
The FDA has approved a...
01/28/2025
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
illustration of a brain
News
01/12/2026
Maria Mantas
Processing speed remains one of the most severely impaired cognitive domains in people with schizophrenia, according to a large systematic review and meta-analysis published in JAMA Psychiatry.
Processing speed remains one of the most severely impaired cognitive domains in people with schizophrenia, according to a large systematic review and meta-analysis published in JAMA Psychiatry.
Processing speed remains one of...
01/12/2026
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
woman on a hill
News
01/09/2026
Maria Mantas
A new multi-site study suggests that while delay discounting is elevated in patients with remitted MDD, it neither changes after antidepressant medication discontinuation nor predicts subsequent depressive relapse.
A new multi-site study suggests that while delay discounting is elevated in patients with remitted MDD, it neither changes after antidepressant medication discontinuation nor predicts subsequent depressive relapse.
A new multi-site study suggests...
01/09/2026
Psych Congress Network
An illustration of a brain
News
01/06/2026
Sarah Fleming
In a study published in Schizophrenia Research, investigators examined whether disease duration or antipsychotic exposure explains increases in brain age among patients with schizophrenia using MRI-based machine-learning models.
In a study published in Schizophrenia Research, investigators examined whether disease duration or antipsychotic exposure explains increases in brain age among patients with schizophrenia using MRI-based machine-learning models.
In a study published in...
01/06/2026
Psych Congress Network
Two pill bottles tipped over with pills on a table
News
01/06/2026
Sarah Fleming
New research published in BMJ Mental Health leveraged national United Kingdom (UK) health registry data to investigate whether selective serotonin reuptake inhibitor (SSRI) treatment in adolescents with unipolar depression influences later...
New research published in BMJ Mental Health leveraged national United Kingdom (UK) health registry data to investigate whether selective serotonin reuptake inhibitor (SSRI) treatment in adolescents with unipolar depression influences later...
New research published in BMJ...
01/06/2026
Psych Congress Network
artificial intelligence
News
01/05/2026
Maria Mantas
A large UK study reports that an artificial intelligence (AI)–enabled clinical prediction model may accurately identify individuals at risk of developing psychotic disorders or bipolar disorders.
A large UK study reports that an artificial intelligence (AI)–enabled clinical prediction model may accurately identify individuals at risk of developing psychotic disorders or bipolar disorders.
A large UK study reports that an...
01/05/2026
Psych Congress Network
a group of clinicians
News
01/02/2026
Maria Mantas
A collaborative care model tailored for low-resource primary care settings did not improve outcomes beyond enhanced usual care for adults with OUD and co-occurring depression and/or PTSD.
A collaborative care model tailored for low-resource primary care settings did not improve outcomes beyond enhanced usual care for adults with OUD and co-occurring depression and/or PTSD.
A collaborative care model...
01/02/2026
Psych Congress Network
A woman with insomnia lying in bed trying to sleep
News
01/02/2026
Sarah Fleming
A narrative review in PLOS Mental Health synthesizes evidence on the bidirectional relationship between sleep and psychiatric disorders and highlights shared neurobiological mechanisms that span major depression, bipolar disorder (BD),...
A narrative review in PLOS Mental Health synthesizes evidence on the bidirectional relationship between sleep and psychiatric disorders and highlights shared neurobiological mechanisms that span major depression, bipolar disorder (BD),...
A narrative review in PLOS...
01/02/2026
Psych Congress Network
A person's hands typing on a smartphone
News
12/29/2025
Sarah Fleming
A smartphone-delivered digital cognitive behavioral therapy (DCBT) program significantly improved symptoms of generalized anxiety disorder (GAD) in adults, according to a randomized clinical trial published in JAMA Network Open.
A smartphone-delivered digital cognitive behavioral therapy (DCBT) program significantly improved symptoms of generalized anxiety disorder (GAD) in adults, according to a randomized clinical trial published in JAMA Network Open.
A smartphone-delivered digital...
12/29/2025
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
Greg Mattingly, MD
Videos
01/09/2026
Greg Mattingly, MD
Psych Congress Co-Chair Greg Mattingly, MD, breaks down the key pharmacologic differences between the US Food and Drug Administration (FDA)-approved vesicular monoamine transporter 2 (VMAT-2) inhibitors for the treatment of TD.
Psych Congress Co-Chair Greg Mattingly, MD, breaks down the key pharmacologic differences between the US Food and Drug Administration (FDA)-approved vesicular monoamine transporter 2 (VMAT-2) inhibitors for the treatment of TD.
Psych Congress Co-Chair Greg...
01/09/2026
Psych Congress Network
Greg Mattingly, MD
Videos
01/09/2026
Greg Mattingly, MD
Psych Congress Co-Chair Greg Mattingly, MD, breaks down the key pharmacologic differences between the US Food and Drug Administration (FDA)-approved vesicular monoamine transporter 2 (VMAT-2) inhibitors for the treatment of TD.
Psych Congress Co-Chair Greg Mattingly, MD, breaks down the key pharmacologic differences between the US Food and Drug Administration (FDA)-approved vesicular monoamine transporter 2 (VMAT-2) inhibitors for the treatment of TD.
Psych Congress Co-Chair Greg...
01/09/2026
Psych Congress Network
Steven Chan, MD, MBA
Videos
01/07/2026
Steven Chan, MD, MBA
In this video, Psych Congress Steering Committee Member Steven Chan, MD, MBA, FAPA, FAMIA, offers an overview of the most pressing topics in digital mental health.
In this video, Psych Congress Steering Committee Member Steven Chan, MD, MBA, FAPA, FAMIA, offers an overview of the most pressing topics in digital mental health.
In this video, Psych Congress...
01/07/2026
Psych Congress Network
Michael Asbach, DMsc, PA-C
Videos
12/08/2025
Michael Asbach, DMSc, PA-C
In this video, Michael Asbach, DMSc, PA-C, walks clinicians through some key clinical considerations for navigating diagnostic ambiguity when assessing patients for bipolar II disorder.
In this video, Michael Asbach, DMSc, PA-C, walks clinicians through some key clinical considerations for navigating diagnostic ambiguity when assessing patients for bipolar II disorder.
In this video, Michael Asbach,...
12/08/2025
Psych Congress Network
Desiree Matthews, PMHNP-BC
Videos
12/03/2025
Desiree Matthews, PHMNP-BC
In this video filmed at Psych Congress 2025, Steering Committee member Desiree Matthews, PMHNP-BC, discusses the ways in which digital tools can be leveraged to reduce provider burnout.
In this video filmed at Psych Congress 2025, Steering Committee member Desiree Matthews, PMHNP-BC, discusses the ways in which digital tools can be leveraged to reduce provider burnout.
In this video filmed at Psych...
12/03/2025
Psych Congress Network
Craig Chepke, MD, DFAPA
Videos
12/01/2025
Craig Chepke, MD, DFAPA
In this video, Craig Chepke, MD, DFAPA, discusses real-world findings that clinicians should be aware of when considering the use of oral or LAI antipsychotics for schizophrenia treatment.
In this video, Craig Chepke, MD, DFAPA, discusses real-world findings that clinicians should be aware of when considering the use of oral or LAI antipsychotics for schizophrenia treatment.
In this video, Craig Chepke, MD,...
12/01/2025
Psych Congress Network
Timothy Wilens, MD
Videos
11/14/2025
Timothy Wilens, MD
In this video filmed on-site at Psych Congress 2025, faculty member Timothy Wilens, MD, discusses the role that digital therapeutics may play in the management of attention-deficit/hyperactivity disorder (ADHD).
In this video filmed on-site at Psych Congress 2025, faculty member Timothy Wilens, MD, discusses the role that digital therapeutics may play in the management of attention-deficit/hyperactivity disorder (ADHD).
In this video filmed on-site at...
11/14/2025
Psych Congress Network
Jonathan Meyer, MD
Videos
11/11/2025
Jonathan Meyer, MD
Filmed at the 2025 Psych Congress, Jonathan Meyer, MD, offers an updated approach for clinicians navigating clozapine monitoring following the end of Risk Evaluation and Mitigation Strategy (REMS) program.
Filmed at the 2025 Psych Congress, Jonathan Meyer, MD, offers an updated approach for clinicians navigating clozapine monitoring following the end of Risk Evaluation and Mitigation Strategy (REMS) program.
Filmed at the 2025 Psych...
11/11/2025
Psych Congress Network
Edward Kaftarian, MD
Videos
11/04/2025
Edward Kaftarian, MD
In this video, Psych Congress Steering Committee Member Edward Kaftarian, MD, dives into potential legal gray areas that clinicians may encounter when engaging in cross-state telepsychiatry.
In this video, Psych Congress Steering Committee Member Edward Kaftarian, MD, dives into potential legal gray areas that clinicians may encounter when engaging in cross-state telepsychiatry.
In this video, Psych Congress...
11/04/2025
Psych Congress Network
Timothy Wilens, MD
Videos
10/17/2025
Timothy Wilens, MD
In this insightful discussion, Psych Congress Faculty Member Timothy Wilens, MD, dissects the challenges clinicians may face when diagnosing and treating common psychiatric comorbidities in individuals with ADHD.
In this insightful discussion, Psych Congress Faculty Member Timothy Wilens, MD, dissects the challenges clinicians may face when diagnosing and treating common psychiatric comorbidities in individuals with ADHD.
In this insightful discussion,...
10/17/2025
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
Mark Olfson, MD, MPH
Quiz
01/16/2026
Maria Mantas
Are you caught up with the latest research on telehealth use patterns?
Are you caught up with the latest research on telehealth use patterns?
Are you caught up with the...
01/16/2026
Psych Congress Network
illustration of a laptop screen displaying a test
Quiz
12/22/2025
Maria Mantas
Do you remember the findings from this systematic review?
Do you remember the findings from this systematic review?
Do you remember the findings...
12/22/2025
Psych Congress Network
Joseph Goldberg, MD
Quiz
12/03/2025
Joseph F. Goldberg, MD
Test your knowledge with this quick quiz!
Test your knowledge with this quick quiz!
Test your knowledge with this...
12/03/2025
Psych Congress Network
Pop quiz written on a blackboard with white chalk
Quiz
11/19/2025
Brionna Mendoza
Test your knowledge with this quiz!
Test your knowledge with this quiz!
Test your knowledge with this...
11/19/2025
Psych Congress Network
quiz
Quiz
11/10/2025
Maria Mantas
Test your knowledge with this quick quiz!
Test your knowledge with this quick quiz!
Test your knowledge with this...
11/10/2025
Psych Congress Network
a teenager's hand putting a bag of white pills into another teenager's hand.
Quiz
10/23/2025
Curb misuse before it starts—test your diversion-prevention game in 3 quick questions.
Curb misuse before it starts—test your diversion-prevention game in 3 quick questions.
Curb misuse before it...
10/23/2025
Psych Congress Network
Edward Kaftarian, MD
Quiz
10/09/2025
Edward Kaftarian, MD
Do you remember Dr Kaftarian's recommended strategies for building patient rapport via telehealth?
Do you remember Dr Kaftarian's recommended strategies for building patient rapport via telehealth?
Do you remember Dr Kaftarian's...
10/09/2025
Psych Congress Network
A woman sleeping peacefully
Quiz
10/09/2025
Sleep and ADHD intersect—see if your management playbook is up to date in 3 quick questions.
Sleep and ADHD intersect—see if your management playbook is up to date in 3 quick questions.
Sleep and ADHD intersect—see if...
10/09/2025
Psych Congress Network
Blocks that spell ADHD with pills and a stethoscope
Quiz
10/08/2025
Rethink ADHD beyond stimulants—test your non-stimulant savvy with 3 quick questions.
Rethink ADHD beyond stimulants—test your non-stimulant savvy with 3 quick questions.
Rethink ADHD beyond...
10/08/2025
Psych Congress Network
A boy sleeping peacefully.
Quiz
09/29/2025
How well do you know the evidence on ADHD and sleep? Take this quick quiz to find out.
How well do you know the evidence on ADHD and sleep? Take this quick quiz to find out.
How well do you know the...
09/29/2025
Psych Congress Network