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FDA Updates

Latest News

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 sign
News
01/10/2025
Brionna Mendoza
Posdinemab, a phosphorylated tau-directed monoclonal antibody (mAb) being studied for the treatment of early Alzheimer disease (AD), was granted Fast Track designation by the US Food and Drug Administration (FDA).
Posdinemab, a phosphorylated tau-directed monoclonal antibody (mAb) being studied for the treatment of early Alzheimer disease (AD), was granted Fast Track designation by the US Food and Drug Administration (FDA).
Posdinemab, a phosphorylated...
01/10/2025
Psych Congress Network
Increase in Suicidality Associated With FDA Black Box Warning Implementation
News
10/11/2024
Evi Arthur
Black box warnings on antidepressants from the FDA warning of increased risk of suicidality were associated with a decline in mental health treatment and an increase in suicide attempts and deaths in young people, according to a systematic...
Black box warnings on antidepressants from the FDA warning of increased risk of suicidality were associated with a decline in mental health treatment and an increase in suicide attempts and deaths in young people, according to a systematic...
Black box warnings on...
10/11/2024
Psych Congress Network
FDA approval featuring craig chepke
News
09/27/2024
Meagan Thistle
The US Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults.
The US Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults.
The US Food and Drug...
09/27/2024
Psych Congress Network
fda building sign
News
08/16/2024
Brionna Mendoza
The US Food and Drug Administration (FDA) last week rejected the new drug application (NDA) from Lykos Therapeutics for midomafetamine (MDMA) capsules for the treatment of post-traumatic stress disorder (PTSD) in conjunction with...
The US Food and Drug Administration (FDA) last week rejected the new drug application (NDA) from Lykos Therapeutics for midomafetamine (MDMA) capsules for the treatment of post-traumatic stress disorder (PTSD) in conjunction with...
The US Food and Drug...
08/16/2024
Psych Congress Network
FDA Considers Supplemental NDA for Brexpiprazole Plus Sertraline for PTSD
News
07/24/2024
Jolynn Tumolo
The US Food and Drug Administration recently accepted a supplemental New Drug Application for brexpiprazole in combination with sertraline for the treatment of adults with PTSD, announced codevelopers Otsuka Pharmaceutical Co. Ltd. and H....
The US Food and Drug Administration recently accepted a supplemental New Drug Application for brexpiprazole in combination with sertraline for the treatment of adults with PTSD, announced codevelopers Otsuka Pharmaceutical Co. Ltd. and H....
The US Food and Drug...
07/24/2024
Psych Congress Network
stethoscope, pills, and a brain
News
09/25/2025
Maria Mantas
Stimulant use for the treatment of attention-deficit/hyperactivity disorder (ADHD) was associated with higher occurrence of psychotic symptoms, psychotic disorders, and bipolar disorder (BD), according to a systematic review.
Stimulant use for the treatment of attention-deficit/hyperactivity disorder (ADHD) was associated with higher occurrence of psychotic symptoms, psychotic disorders, and bipolar disorder (BD), according to a systematic review.
Stimulant use for the treatment...
09/25/2025
Psych Congress Network
Katherine Warburton, Stephen Stahl, and Roberto Carrara
News
09/19/2025
Maria Mantas
Discussions of ethical intervention, patient autonomy, and justice reform took center stage during the keynote address at the 2025 Psych Congress on Wednesday evening.
Discussions of ethical intervention, patient autonomy, and justice reform took center stage during the keynote address at the 2025 Psych Congress on Wednesday evening.
Discussions of ethical...
09/19/2025
Psych Congress Network
DNA strand
News
09/15/2025
Jolynn Tumolo
Clinician use of a specific weighted multigene pharmacogenomic (PGx) test significantly improved outcomes in adult patients with major depressive disorder (MDD) with at least 1 treatment failure, according to meta-analysis results.
Clinician use of a specific weighted multigene pharmacogenomic (PGx) test significantly improved outcomes in adult patients with major depressive disorder (MDD) with at least 1 treatment failure, according to meta-analysis results.
Clinician use of a specific...
09/15/2025
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
cannabis plant and CBD oil
News
09/11/2025
Maria Mantas
Cannabis products that contained high concentrations of delta-9-tetrahydrocannabinol (THC) were associated with psychosis, schizophrenia, and cannabis use disorder (CUD), according to a systematic review.
Cannabis products that contained high concentrations of delta-9-tetrahydrocannabinol (THC) were associated with psychosis, schizophrenia, and cannabis use disorder (CUD), according to a systematic review.
Cannabis products that contained...
09/11/2025
Psych Congress Network
child embraces mother
News
09/02/2025
Maria Mantas
Child depression at ages 10 and 11 years during the COVID-19 pandemic was significantly associated with later maternal depression, according to longitudinal study results.
Child depression at ages 10 and 11 years during the COVID-19 pandemic was significantly associated with later maternal depression, according to longitudinal study results.
Child depression at ages 10 and...
09/02/2025
Psych Congress Network
An orange prescription container with generic pills spilling out in front of it
News
08/27/2025
Jolynn Tumolo
Patients with attention-deficit/hyperactivity disorder (ADHD) who began drug treatment within 3 months of diagnosis had significantly reduced rates of suicidal behaviors, substance misuse, traffic accidents, and criminality.
Patients with attention-deficit/hyperactivity disorder (ADHD) who began drug treatment within 3 months of diagnosis had significantly reduced rates of suicidal behaviors, substance misuse, traffic accidents, and criminality.
Patients with...
08/27/2025
Psych Congress Network
An illustrated picture shows two cartoon doctors, one holding up a magnifying glass to a cartoon brain.
News
08/25/2025
Jolynn Tumolo
An investigational prescription digital therapeutic targeting negative symptoms in patients with schizophrenia met its primary endpoint in a pivotal phase 3 randomized controlled study.
An investigational prescription digital therapeutic targeting negative symptoms in patients with schizophrenia met its primary endpoint in a pivotal phase 3 randomized controlled study.
An investigational prescription...
08/25/2025
Psych Congress Network
tired man rubs eyes
News
08/18/2025
Jolynn Tumolo
Compared with older adults without insomnia, older adults with the sleep disorder experienced a 3-fold greater increase in depressed mood and depressive symptoms after exposure to an inflammatory challenge, according to study findings.
Compared with older adults without insomnia, older adults with the sleep disorder experienced a 3-fold greater increase in depressed mood and depressive symptoms after exposure to an inflammatory challenge, according to study findings.
Compared with older adults...
08/18/2025
Psych Congress Network
A woman lies in bed awake due to insomnia
News
08/15/2025
Brionna Mendoza
A single dose of tetrahydrocannabinol/cannabidiol (THC/CBD) resulted in worse sleep for study participants with insomnia.
A single dose of tetrahydrocannabinol/cannabidiol (THC/CBD) resulted in worse sleep for study participants with insomnia.
A single dose of...
08/15/2025
Neurology

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
Amber Hoberg, MSN, APRN, PMHNP-BC
Videos
09/23/2025
Amber Hoberg, MSN, APRN, PMHNP-BC
In this video taken on-site at the 2025 Psych Congress, Steering Committee Member Amber Hoberg, PMHNP-BC, walks clinicians through her approach to managing some common comorbid conditions that may impact schizophrenia patients.
In this video taken on-site at the 2025 Psych Congress, Steering Committee Member Amber Hoberg, PMHNP-BC, walks clinicians through her approach to managing some common comorbid conditions that may impact schizophrenia patients.
In this video taken on-site at...
09/23/2025
Psych Congress Network
Edward Kaftarian, MD
Videos
09/09/2025
Edward Kaftarian, MD
In this video, Psych Congress Steering Committee Member Edward Kaftarian, MD, provides an overview of recent developments in reimbursement policies for telehealth services.
In this video, Psych Congress Steering Committee Member Edward Kaftarian, MD, provides an overview of recent developments in reimbursement policies for telehealth services.
In this video, Psych Congress...
09/09/2025
Psych Congress Network
Brooke Kempf, PMHNP-BC
Videos
09/05/2025
Brooke Kempf, MSN, PMHNP-BC
In this video, Psych Congress Steering Committee Member Brooke Kempf, PMHNP-BC, discusses how the development of muscarinic-targeting treatments is shaping the future of schizophrenia care.
In this video, Psych Congress Steering Committee Member Brooke Kempf, PMHNP-BC, discusses how the development of muscarinic-targeting treatments is shaping the future of schizophrenia care.
In this video, Psych Congress...
09/05/2025
Psych Congress Network
Craig Chepke, MD, DFAPA
Videos
09/05/2025
Craig Chepke, MD, DFAPA
Craig Chepke, MD, DFAPA, discusses how sleep disorders manifest in psychiatric patients and novel treatments available for these conditions.
Craig Chepke, MD, DFAPA, discusses how sleep disorders manifest in psychiatric patients and novel treatments available for these conditions.
Craig Chepke, MD, DFAPA,...
09/05/2025
Psych Congress Network
Greg Mattingly, MD
Videos
09/04/2025
Greg Mattingly, MD
In this video, filmed at the 2025 NP Institute, Psych Congress Co-Chair Greg Mattingly, MD, provides an insightful overview of the telltale signs that can help clinicians distinguish TD from other movement disorders.
In this video, filmed at the 2025 NP Institute, Psych Congress Co-Chair Greg Mattingly, MD, provides an insightful overview of the telltale signs that can help clinicians distinguish TD from other movement disorders.
In this video, filmed at the...
09/04/2025
Psych Congress Network
Greg Mattingly, MD
Videos
09/04/2025
Greg Mattingly, MD
In this video, filmed at the 2025 NP Institute, Psych Congress Co-Chair Greg Mattingly, MD, provides an insightful overview of the telltale signs that can help clinicians distinguish TD from other movement disorders.
In this video, filmed at the 2025 NP Institute, Psych Congress Co-Chair Greg Mattingly, MD, provides an insightful overview of the telltale signs that can help clinicians distinguish TD from other movement disorders.
In this video, filmed at the...
09/04/2025
Psych Congress Network
Edward Kaftarian, MD
Videos
09/03/2025
Edward Kaftarian, MD
In this video, filmed at Psych Congress Elevate 2025, Steering Committee Member Edward Kaftarian, MD, walks clinicians through current and forthcoming regulations regarding the prescription of controlled substances via telehealth.
In this video, filmed at Psych Congress Elevate 2025, Steering Committee Member Edward Kaftarian, MD, walks clinicians through current and forthcoming regulations regarding the prescription of controlled substances via telehealth.
In this video, filmed at Psych...
09/03/2025
Psych Congress Network
Hara Oyedeji
Videos
08/11/2025
Hara Oyedeji, APRN, PHMNP-BC, MS Ed
In this video, Psych Congress NP Institute Faculty Member Hara Oyedeji, APRN, PMHNP-BC, MSEd, discusses the demographic disparities that exist in the diagnosis of schizophrenia.
In this video, Psych Congress NP Institute Faculty Member Hara Oyedeji, APRN, PMHNP-BC, MSEd, discusses the demographic disparities that exist in the diagnosis of schizophrenia.
In this video, Psych Congress NP...
08/11/2025
Psych Congress Network
Edward Kaftarian, MD
Videos
08/07/2025
Edward Kaftarian, MD
In this video, Edward Kaftarian, MD, discusses effective strategies for building patient rapport via telehealth.
In this video, Edward Kaftarian, MD, discusses effective strategies for building patient rapport via telehealth.
In this video, Edward Kaftarian,...
08/07/2025
Psych Congress Network
Craig Chepke, MD, DFAPA
Videos
08/05/2025
Craig Chepke, MD, DFAPA
Psych Congress Elevate Co-Chair and Scientific Director Craig Chepke, MD, DFAPA, shares an overview of some of the most promising clinical findings regarding muscarinic receptor activators.
Psych Congress Elevate Co-Chair and Scientific Director Craig Chepke, MD, DFAPA, shares an overview of some of the most promising clinical findings regarding muscarinic receptor activators.
Psych Congress Elevate Co-Chair...
08/05/2025
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
a cloud with three z's
Quiz
09/19/2025
Can you optimize ADHD control and protect sleep? Take this quick quiz on viloxazine ER’s role in patients with nighttime challenges.
Can you optimize ADHD control and protect sleep? Take this quick quiz on viloxazine ER’s role in patients with nighttime challenges.
Can you optimize ADHD control...
09/19/2025
Psych Congress Network
Dr Greg Mattingly
Quiz
09/17/2025
How well do you know the clinical impact and unique mechanism of viloxazine ER? Take this short quiz to find out.
How well do you know the clinical impact and unique mechanism of viloxazine ER? Take this short quiz to find out.
How well do you know the...
09/17/2025
Psych Congress Network
Craig Chepke, MD, DFAPA
Quiz
09/12/2025
Craig Chepke, MD, DFAPA
Do you remember the details of this interview with Dr Chepke?
Do you remember the details of this interview with Dr Chepke?
Do you remember the details of...
09/12/2025
Psych Congress Network
medication
Quiz
09/09/2025
What does research reveal about the risk of non-stimulants? Test your understanding of ADHD treatment and stimulant misuse.
What does research reveal about the risk of non-stimulants? Test your understanding of ADHD treatment and stimulant misuse.
What does research reveal about...
09/09/2025
Psych Congress Network
Dr Rakesh Jain
Quiz
09/04/2025
Think you understand the role of non-stimulants in ADHD treatment? Take this quick quiz to test your knowledge of viloxazine ER.
Think you understand the role of non-stimulants in ADHD treatment? Take this quick quiz to test your knowledge of viloxazine ER.
Think you understand the role of...
09/04/2025
Psych Congress Network
Dr Rakesh Jain
Quiz
09/03/2025
How well do you know the evolving landscape of non-stimulant ADHD treatments? Take this quick quiz to find out.
How well do you know the evolving landscape of non-stimulant ADHD treatments? Take this quick quiz to find out.
How well do you know the...
09/03/2025
Psych Congress Network
Wooden blocks spelling QUIZ
Quiz
09/02/2025
Can viloxazine ER enhance stimulant therapy in pediatric ADHD? Take this quick quiz to test your knowledge.
Can viloxazine ER enhance stimulant therapy in pediatric ADHD? Take this quick quiz to test your knowledge.
Can viloxazine ER enhance...
09/02/2025
Psych Congress Network
Drs Mattingly, Price, Amann Part 3
Quiz
08/27/2025
Take this quick quiz to test your knowledge on combination treatment strategies, novel mechanisms, and how emerging data is reshaping care for complex patients of all ages.
Take this quick quiz to test your knowledge on combination treatment strategies, novel mechanisms, and how emerging data is reshaping care for complex patients of all ages.
Take this quick quiz to test...
08/27/2025
Psych Congress Network
Drs Mattingly, Price, Amann Part 2
Quiz
08/25/2025
Discover how viloxazine ER compares to atomoxetine in real-world ADHD treatment—test your knowledge with this short, expert-driven quiz.
Discover how viloxazine ER compares to atomoxetine in real-world ADHD treatment—test your knowledge with this short, expert-driven quiz.
Discover how viloxazine ER...
08/25/2025
Psych Congress Network
blocks spelling out the word "quiz"
Quiz
08/15/2025
In which of the following scenarios does the American Psychiatric Association (APA) recommend initiating clozapine in patients with schizophrenia?
In which of the following scenarios does the American Psychiatric Association (APA) recommend initiating clozapine in patients with schizophrenia?
In which of the following...
08/15/2025
Psych Congress Network