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FDA Updates

Latest News

FDA building
News
01/28/2025
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
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
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
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
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
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
FDA building sign
News
07/23/2024
The US Food and Drug Administration (FDA) has again declined Swedish drug manufacturer Orexo’s New Drug Application (NDA) for OX125, a high-dose naloxone nasal spray for opioid overdose reversal.
The US Food and Drug Administration (FDA) has again declined Swedish drug manufacturer Orexo’s New Drug Application (NDA) for OX125, a high-dose naloxone nasal spray for opioid overdose reversal.
The US Food and Drug...
07/23/2024
Psych Congress Network
lab work
News
07/08/2024
A pharmacokinetics study of AD04, a potential treatment for AUD, is designed to meet an FDA requirement for an upcoming phase 3 trial and is expected to last 6 months.
A pharmacokinetics study of AD04, a potential treatment for AUD, is designed to meet an FDA requirement for an upcoming phase 3 trial and is expected to last 6 months.
A pharmacokinetics study of...
07/08/2024
Psych Congress Network
Video Game Treatment for Adults With ADHD Cleared by FDA
News
07/02/2024
AKL-T01 is indicated for adults with primarily inattentive or combined-type ADHD who have a demonstrated attention issue.
AKL-T01 is indicated for adults with primarily inattentive or combined-type ADHD who have a demonstrated attention issue.
AKL-T01 is indicated for adults...
07/02/2024
Psych Congress Network
FDA Approves First Liquid, Non-Stimulant for Pediatric ADHD
News
06/11/2024
The FDA approved Tris Pharma, Inc.’s ONYDA™ XR (clonidine hydrochloride), a once-daily extended-release oral suspension medication, for the treatment of ADHD in patients 6 years and older.
The FDA approved Tris Pharma, Inc.’s ONYDA™ XR (clonidine hydrochloride), a once-daily extended-release oral suspension medication, for the treatment of ADHD in patients 6 years and older.
The FDA approved Tris Pharma,...
06/11/2024
Psych Congress Network
Buprenorphine With Naloxone May Be Safe During Pregnancy for OUD Treatment
News
02/13/2025
When compared to buprenorphine alone, buprenorphine with naloxone during pregnancy may also be a safe treatment option for patients with opioid use disorder (OUD), according to results from a population-based cohort study published in JAMA. 
When compared to buprenorphine alone, buprenorphine with naloxone during pregnancy may also be a safe treatment option for patients with opioid use disorder (OUD), according to results from a population-based cohort study published in JAMA. 
When compared to buprenorphine...
02/13/2025
Psych Congress Network
A person holds a cannabis joint in their hands
News
02/11/2025
A lifetime history of heavy cannabis use in young adults was associated with lower brain activation during a working memory task, according to a study in JAMA Network Open
A lifetime history of heavy cannabis use in young adults was associated with lower brain activation during a working memory task, according to a study in JAMA Network Open
A lifetime history of heavy...
02/11/2025
Neurology
Methylphenidate Improved Driving Performance in Adults
News
02/10/2025
Methylphenidate improved driving performance in adults by reducing lane weaving and speed variation, according to results from a recent randomized controlled trial published in the Journal of Psychopharmacology. 
Methylphenidate improved driving performance in adults by reducing lane weaving and speed variation, according to results from a recent randomized controlled trial published in the Journal of Psychopharmacology. 
Methylphenidate improved driving...
02/10/2025
Psych Congress Network
News
02/07/2025
A recent study published in JAMA Network Open highlights the financial benefits of employer-sponsored behavioral health programs, demonstrating that these programs can result in significant net medical costs savings.
A recent study published in JAMA Network Open highlights the financial benefits of employer-sponsored behavioral health programs, demonstrating that these programs can result in significant net medical costs savings.
A recent study published in JAMA...
02/07/2025
First Report Managed Care
A woman holds her forehead looking stressed
News
02/03/2025
Elevated translocator protein (TSPO) binding, a marker of neuroinflammatory processes, was associated with more pronounced daily suicidal ideation and negative affect during real-world stress in patients with major depressive disorder (MDD).
Elevated translocator protein (TSPO) binding, a marker of neuroinflammatory processes, was associated with more pronounced daily suicidal ideation and negative affect during real-world stress in patients with major depressive disorder (MDD).
Elevated translocator protein...
02/03/2025
Psych Congress Network
Drug Overdose Deaths Overall Decrease from 2022 to 2023
News
01/31/2025
A recent report from the National Center for Health Statistics found many decreases in drug overdose deaths between 2022 and 2023, though certain subsections remained stable or increased year over year, according to the CDC and the National...
A recent report from the National Center for Health Statistics found many decreases in drug overdose deaths between 2022 and 2023, though certain subsections remained stable or increased year over year, according to the CDC and the National...
A recent report from the...
01/31/2025
Psych Congress Network
FDA building
News
01/28/2025
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
Brexpiprazole and Sertraline Combination Treatment Improves PTSD Symptoms
News
01/27/2025
Combining brexpiprazole and sertraline in treatment of post-traumatic stress disorder (PTSD) significantly improved PTSD symptoms when compared with sertraline and placebo treatment, according to results from a randomized clinical trial...
Combining brexpiprazole and sertraline in treatment of post-traumatic stress disorder (PTSD) significantly improved PTSD symptoms when compared with sertraline and placebo treatment, according to results from a randomized clinical trial...
Combining brexpiprazole and...
01/27/2025
Psych Congress Network
IED Linked With Multiple Psychiatric, Neurologic Comorbidities
News
01/24/2025
Intermittent explosive disorder (IED) was found to have many comorbidities, including substance use disorder, neurodegenerative diseases, sleep disorders, and many somatic diseases, according to a recent cohort study published in JAMA...
Intermittent explosive disorder (IED) was found to have many comorbidities, including substance use disorder, neurodegenerative diseases, sleep disorders, and many somatic diseases, according to a recent cohort study published in JAMA...
Intermittent explosive disorder...
01/24/2025
Psych Congress Network
ADHD Symptoms Associated With Lower Academic Performance in College Students
News
01/23/2025
Symptoms of attention-deficit/hyperactivity disorder (ADHD) were associated with a lower academic performance in college students, especially those with inattention symptoms, according to a recent systematic review published in the Journal of...
Symptoms of attention-deficit/hyperactivity disorder (ADHD) were associated with a lower academic performance in college students, especially those with inattention symptoms, according to a recent systematic review published in the Journal of...
Symptoms of...
01/23/2025
Psych Congress Network

Exclusives

andrew penn
Videos
07/01/2024
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,...
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
Steven Chan, MD, MBA, FAPA, FAMIA
Videos
02/14/2025
In this video, Steven Chan, MD, MBA, FAPA, FAMIA, Psych Congress Steering Committee, explains some of the barriers that virtual clinicians should anticipate when weighing digital therapeutic options for major depressive disorder (MDD)...
In this video, Steven Chan, MD, MBA, FAPA, FAMIA, Psych Congress Steering Committee, explains some of the barriers that virtual clinicians should anticipate when weighing digital therapeutic options for major depressive disorder (MDD)...
In this video, Steven Chan, MD,...
02/14/2025
Psych Congress Network
Steven Chan, MD, MBA, FAPA, FAMIA
Videos
02/10/2025
Steven Chan, MD, MBA, FAPA, FAMIA, explains how telehealth providers can explore and adopt digital therapeutics for their virtual practices.
Steven Chan, MD, MBA, FAPA, FAMIA, explains how telehealth providers can explore and adopt digital therapeutics for their virtual practices.
Steven Chan, MD, MBA, FAPA,...
02/10/2025
Psych Congress Network
Brooke Kempf, PMHNP-BC
Videos
02/05/2025
What role do long-acting injectables (LAIs) play in improving long-term outcomes for patients with schizophrenia? In this discussion, Brooke Kempf, PMHNP-BC, highlights the benefits of early LAI initiation, from reducing relapse rates and...
What role do long-acting injectables (LAIs) play in improving long-term outcomes for patients with schizophrenia? In this discussion, Brooke Kempf, PMHNP-BC, highlights the benefits of early LAI initiation, from reducing relapse rates and...
What role do long-acting...
02/05/2025
Psych Congress Network
Edward Kaftarian, MD.
Videos
01/30/2025
Edward Kaftarian, MD, shares his insights on the clinical, legal, and technological factors that impact virtual care for SUD.
Edward Kaftarian, MD, shares his insights on the clinical, legal, and technological factors that impact virtual care for SUD.
Edward Kaftarian, MD, shares...
01/30/2025
Psych Congress Network
Brooke Kempf
Videos
01/06/2025
Kempf emphasizes the power of patient education, addressing myths, and involving families to ease the daily medication burden. 
Kempf emphasizes the power of patient education, addressing myths, and involving families to ease the daily medication burden. 
Kempf emphasizes the power of...
01/06/2025
Psych Congress Network
Desiree Matthews, PMHNP-BC, CEO
Videos
01/06/2025
In this video, Desiree Matthews, PMHNP-BC, discusses how to navigate insurance policies when treating tardive dyskinesia.
In this video, Desiree Matthews, PMHNP-BC, discusses how to navigate insurance policies when treating tardive dyskinesia.
In this video, Desiree Matthews,...
01/06/2025
Psych Congress Network
Desiree Matthews, PMHNP-BC, CEO
Videos
01/06/2025
In this video, Desiree Matthews, PMHNP-BC, discusses how to navigate insurance policies when treating tardive dyskinesia.
In this video, Desiree Matthews, PMHNP-BC, discusses how to navigate insurance policies when treating tardive dyskinesia.
In this video, Desiree Matthews,...
01/06/2025
Psych Congress Network
Andrew Penn, PMHNP-BC
Videos
12/05/2024
In this video, Andrew Penn, PMHNP-BC, NP, CNS, MS, RN offers some key clinical takeaways from his session on deprescribing and how it even has a place when treating patients living with serious mental illness like schizophrenia.
In this video, Andrew Penn, PMHNP-BC, NP, CNS, MS, RN offers some key clinical takeaways from his session on deprescribing and how it even has a place when treating patients living with serious mental illness like schizophrenia.
In this video, Andrew Penn,...
12/05/2024
Psych Congress Network
Rebecca Barbee, MSPAS, PA-C, CAQ-Psych
Videos
12/05/2024
Rebecca Barbee, MSPAS, PA-C, CAQ-Psych, explains the differences between dystonia, akathisia, drug-induced Parkinsonism, and tardive dyskinesia, as well as the different management approaches for each.
Rebecca Barbee, MSPAS, PA-C, CAQ-Psych, explains the differences between dystonia, akathisia, drug-induced Parkinsonism, and tardive dyskinesia, as well as the different management approaches for each.
Rebecca Barbee, MSPAS, PA-C,...
12/05/2024
Psych Congress Network
Edward Kaftarian, MD.
Videos
12/03/2024
Edward Kaftarian, MD, offers some practical tips for maintaining regulatory compliance while managing a busy telehealth practice.
Edward Kaftarian, MD, offers some practical tips for maintaining regulatory compliance while managing a busy telehealth practice.
Edward Kaftarian, MD, offers...
12/03/2024
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
How many US Psychiatric Hospitals Provided Medications for OUD?
Quiz
02/06/2025
Do you remember the details of this study?
Do you remember the details of this study?
Do you remember the details of...
02/06/2025
Psych Congress Network
Four people ponder with question marks over their heads
Quiz
02/03/2025
Test your knowledge with this quick quiz!
Test your knowledge with this quick quiz!
Test your knowledge with this...
02/03/2025
Psych Congress Network
How many people with anxiety disorders receive treatment?
Quiz
01/28/2025
Test your statistical knowledge!
Test your statistical knowledge!
Test your statistical knowledge!
01/28/2025
Psych Congress Network
How can clinicians help patients with ADHD transition from adolescence to adulthood?
Quiz
01/22/2025
Do you remember this interview with Dr Wilens?
Do you remember this interview with Dr Wilens?
Do you remember this interview...
01/22/2025
Psych Congress Network
Three illustrated faces, one sad, one neutral, one happy, with a human hand picking up the happy face
Quiz
01/21/2025
Test your knowledge with this quiz!
Test your knowledge with this quiz!
Test your knowledge with this...
01/21/2025
Psych Congress Network
Quiz
Quiz
01/15/2025
According to a recent study published in the Journal of Affective Disorders, what percentage of people experienced hypomanic symptoms during a major depressive disorder (MDD) episode?
According to a recent study published in the Journal of Affective Disorders, what percentage of people experienced hypomanic symptoms during a major depressive disorder (MDD) episode?
According to a recent study...
01/15/2025
Psych Congress Network
Which U.S. region saw the most fentanyl pill seizures in 2023?
Quiz
01/15/2025
Do you remember the details of this study?
Do you remember the details of this study?
Do you remember the details of...
01/15/2025
Psych Congress Network
An illustration of a pencil marking answers on a quiz sheet.
Expert Insights Quiz
01/06/2025
Test your knowledge with this quiz!
Test your knowledge with this quiz!
Test your knowledge with this...
01/06/2025
Psych Congress Network
How long does worry need to be present in order to diagnose GAD?
Quiz
01/03/2025
Test your diagnostic knowledge!
Test your diagnostic knowledge!
Test your diagnostic knowledge!
01/03/2025
Psych Congress Network
Pop quiz written on a blackboard with white chalk
Quiz
12/23/2024
Test your knowledge with this quick quiz!
Test your knowledge with this quick quiz!
Test your knowledge with this...
12/23/2024
Psych Congress Network