Skip to main content

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
Three illustrated faces, one sad, one neutral, one happy, with a human hand picking up the happy face
News
05/04/2026
Brionna Mendoza
A randomized clinical trial published in JAMA Psychiatry found that oral semaglutide may improve effort-based decision-making in adults with major depressive disorder (MDD).
A randomized clinical trial published in JAMA Psychiatry found that oral semaglutide may improve effort-based decision-making in adults with major depressive disorder (MDD).
A randomized clinical trial...
05/04/2026
Psych Congress Network
A patient receives psychedelic-assisted therapy
News
04/29/2026
Brionna Mendoza
President Donald J. Trump signed an executive order titled “Accelerating Medical Treatments for Serious Mental Illness,” which aims to expand psychedelic therapy access for significant mental health issues, such as suicidality, major...
President Donald J. Trump signed an executive order titled “Accelerating Medical Treatments for Serious Mental Illness,” which aims to expand psychedelic therapy access for significant mental health issues, such as suicidality, major...
President Donald J. Trump signed...
04/29/2026
Psych Congress Network
a female soldier stands in front of a row of American flags
News
04/22/2026
Maria Mantas
Active navigated transcranial magnetic stimulation (TMS) added to intensive residential treatment was associated with greater reduction of symptoms in patients with combat-related posttraumatic stress disorder (PTSD) than sham TMS.
Active navigated transcranial magnetic stimulation (TMS) added to intensive residential treatment was associated with greater reduction of symptoms in patients with combat-related posttraumatic stress disorder (PTSD) than sham TMS.
Active navigated transcranial...
04/22/2026
Psych Congress Network
A doctor sits at a table holding a pill bottle in one hand while filling out paperwork
News
04/14/2026
Brionna Mendoza
A systematic review published in Frontiers in Psychiatry reports that algorithm-guided treatment (AGT) is generally associated with improved remission rates and more timely treatment modifications compared with treatment as usual (TAU).
A systematic review published in Frontiers in Psychiatry reports that algorithm-guided treatment (AGT) is generally associated with improved remission rates and more timely treatment modifications compared with treatment as usual (TAU).
A systematic review published in...
04/14/2026
Psych Congress Network
a person attempts to pick up a glass of water
News
04/14/2026
Maria Mantas
Neurocrine Biosciences reported new real-world evidence demonstrating higher treatment persistence with valbenazine (Ingrezza) compared with deutetrabenazine (Austedo XR) among adults with tardive dyskinesia (TD).
Neurocrine Biosciences reported new real-world evidence demonstrating higher treatment persistence with valbenazine (Ingrezza) compared with deutetrabenazine (Austedo XR) among adults with tardive dyskinesia (TD).
Neurocrine Biosciences reported...
04/14/2026
Psych Congress Network
A boy's hand holding a pill that says ADHD
News
04/13/2026
A phase 3 open-label extension trial found viloxazine ER to be safe and effective for the long-term treatment of pediatric ADHD.
A phase 3 open-label extension trial found viloxazine ER to be safe and effective for the long-term treatment of pediatric ADHD.
A phase 3 open-label extension...
04/13/2026
Psych Congress Network
A teddy bear against a blue background wearing a mask and stethoscope.
News
04/10/2026
Brionna Mendoza
Attention-deficit/hyperactivity disorder (ADHD) diagnosis rates in people younger than 30 years in British Columbia, Canada, rose steadily from 2003 to 2023 and appeared to accelerate after both DSM-5 implementation and the COVID-19 pandemic.
Attention-deficit/hyperactivity disorder (ADHD) diagnosis rates in people younger than 30 years in British Columbia, Canada, rose steadily from 2003 to 2023 and appeared to accelerate after both DSM-5 implementation and the COVID-19 pandemic.
Attention-deficit/hyperactivity...
04/10/2026
Psych Congress Network
A profile of a person split in half, one half teal and the other purple, with a swirl line over the head
News
04/07/2026
Brionna Mendoza
Bipolar II disorder (BD-II) is associated with significantly increased mortality, according to a large population-based cohort study published in JAMA Network Open.
Bipolar II disorder (BD-II) is associated with significantly increased mortality, according to a large population-based cohort study published in JAMA Network Open.
Bipolar II disorder (BD-II) is...
04/07/2026
Psych Congress Network
a man with depression looks out a window major depressive disorder
Research Summary
04/01/2026
Brionna Mendoza
A Phase 2b randomized clinical trial found nonsignificant differences in response rate between psilocybin 25 mg, psilocybin 5 mg, and placebo with supporting psychotherapy in treatment-resistant major depressive disorder (MDD).
A Phase 2b randomized clinical trial found nonsignificant differences in response rate between psilocybin 25 mg, psilocybin 5 mg, and placebo with supporting psychotherapy in treatment-resistant major depressive disorder (MDD).
A Phase 2b randomized clinical...
04/01/2026
Psych Congress Network
spilled bottle of white pills
News
04/01/2026
Maria Mantas
Interim results from a phase 2 randomized, double-blind, placebo-controlled trial of tazbentetol demonstrated early signals of efficacy across schizophrenia symptom domains.
Interim results from a phase 2 randomized, double-blind, placebo-controlled trial of tazbentetol demonstrated early signals of efficacy across schizophrenia symptom domains.
Interim results from a phase 2...
04/01/2026
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
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
Desiree Matthews, PMHNP-BC
Videos
03/06/2026
Desiree Matthews, PHMNP-BC
In this video, Desiree Matthews, PMHNP-BC, Steering Committee, Psych Congress, offers several practical considerations for mental health care providers contemplating the use of AI in psychiatric practice.
In this video, Desiree Matthews, PMHNP-BC, Steering Committee, Psych Congress, offers several practical considerations for mental health care providers contemplating the use of AI in psychiatric practice.
In this video, Desiree Matthews,...
03/06/2026
Psych Congress Network
Saundra Jain, MA, PsyD, LPC
Videos
02/20/2026
Saundra Jain, MA, PsyD, LPC
Saundra Jain, MA, PsyD, LPC, discusses how clinicians can leverage digital therapeutics for the treatment of generalized anxiety disorder (GAD).
Saundra Jain, MA, PsyD, LPC, discusses how clinicians can leverage digital therapeutics for the treatment of generalized anxiety disorder (GAD).
Saundra Jain, MA, PsyD, LPC,...
02/20/2026
Psych Congress Network
Edward Kaftarian, MD
Videos
02/09/2026
Edward Kaftarian, MD
Edward Kaftarian, MD, Steering Committee, Psych Congress, provides an update on the current state of HIPAA requirements for clinicians practicing via telehealth.
Edward Kaftarian, MD, Steering Committee, Psych Congress, provides an update on the current state of HIPAA requirements for clinicians practicing via telehealth.
Edward Kaftarian, MD, Steering...
02/09/2026
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
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

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
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
a girl playing a game on a tablet while lying on her stomach
Quiz
04/23/2026
How familiar are you with DTx for the treatment of attention-deficit/hyperactivity disorder? Test your knowledge with this short, multiple-choice quiz.
How familiar are you with DTx for the treatment of attention-deficit/hyperactivity disorder? Test your knowledge with this short, multiple-choice quiz.
How familiar are you with DTx...
04/23/2026
Psych Congress Network
A boy's hand holding a pill that says ADHD
Quiz
04/23/2026
Ready to apply the data? Test your knowledge of viloxazine ER for the long-term treatment of pediatric ADHD.
Ready to apply the data? Test your knowledge of viloxazine ER for the long-term treatment of pediatric ADHD.
Ready to apply the data? Test...
04/23/2026
Psych Congress Network
Brooke Kempf, PMHNP-BC, and Jonathan Meyer, MD
Quiz
04/17/2026
Maria Mantas
Do you remember why anticholinergic agents aren't appropriate treatment options for tardive dyskinesia? Test your knowledge with this quiz!
Do you remember why anticholinergic agents aren't appropriate treatment options for tardive dyskinesia? Test your knowledge with this quiz!
Do you remember why...
04/17/2026
Psych Congress Network
Brooke Kempf, PMHNP-BC, and Jonathan Meyer, MD
Quiz
04/17/2026
Maria Mantas
Do you remember why anticholinergic agents aren't appropriate treatment options for tardive dyskinesia? Test your knowledge with this quiz!
Do you remember why anticholinergic agents aren't appropriate treatment options for tardive dyskinesia? Test your knowledge with this quiz!
Do you remember why...
04/17/2026
Psych Congress Network
Edward Kaftarian, MD
Quiz
03/23/2026
Maria Mantas
Test your knowledge with this faculty insights quiz!
Test your knowledge with this faculty insights quiz!
Test your knowledge with this...
03/23/2026
Psych Congress Network
a printed test, pencil, and clock on a desk
Quiz
02/26/2026
Maria Mantas
Do you remember what the APA guideline recommends? Test your knowledge with this quiz!
Do you remember what the APA guideline recommends? Test your knowledge with this quiz!
Do you remember what the APA...
02/26/2026
Psych Congress Network
blocks spelling out the word "quiz"
Quiz
02/12/2026
Maria Mantas
Do you remember what the research says? Test your knowledge with this quick quiz!
Do you remember what the research says? Test your knowledge with this quick quiz!
Do you remember what the...
02/12/2026
Psych Congress Network
An illustration of a pencil marking answers on a quiz sheet.
Quiz
02/04/2026
Brionna Mendoza
Test your prescribing and administration knowledge with this quiz!
Test your prescribing and administration knowledge with this quiz!
Test your prescribing and...
02/04/2026
Psych Congress Network