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FDA Updates

Latest News

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
FDA building sign
News
07/23/2024
Brionna Mendoza
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
Jolynn Tumolo
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
Evi Arthur
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
Evi Arthur
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
open and spilled bottle of pills
News
04/24/2025
Maria Mantas
A systematic review found no evidence of a beneficial effect from beta-blockers in treating anxiety symptoms in patients with social phobia or panic disorder with or without agoraphobia compared to either placebo or benzodiazepines.
A systematic review found no evidence of a beneficial effect from beta-blockers in treating anxiety symptoms in patients with social phobia or panic disorder with or without agoraphobia compared to either placebo or benzodiazepines.
A systematic review found no...
04/24/2025
Psych Congress Network
tipped over pill bottle with white pills spilling out
News
04/22/2025
Maria Mantas
Fewer than half of all Medicaid managed care plans (MCPs) covered all 4 US Food and Drug Administration (FDA)–approved medications for the treatment of alcohol use disorder (AUD), a cross-sectional study published in JAMA Network Open found.
Fewer than half of all Medicaid managed care plans (MCPs) covered all 4 US Food and Drug Administration (FDA)–approved medications for the treatment of alcohol use disorder (AUD), a cross-sectional study published in JAMA Network Open found.
Fewer than half of all Medicaid...
04/22/2025
Psych Congress Network
Neurons in the brain
News
04/21/2025
Jolynn Tumolo
Late-onset epilepsy (LOE) risk factors in people with cognitive decline include Parkinson disease, early-onset dementia (before age 60), poor cognition, stroke or transient ischemic attacks, Alzheimer disease, and the APOE4 allele.
Late-onset epilepsy (LOE) risk factors in people with cognitive decline include Parkinson disease, early-onset dementia (before age 60), poor cognition, stroke or transient ischemic attacks, Alzheimer disease, and the APOE4 allele.
Late-onset epilepsy (LOE) risk...
04/21/2025
Neurology
strand of DNA
News
04/21/2025
Jolynn Tumolo
A genetic liability for schizophrenia and other mental disorders appears to factor into the associations between traumatic brain injury and mental disorder and suicide, according to study findings.
A genetic liability for schizophrenia and other mental disorders appears to factor into the associations between traumatic brain injury and mental disorder and suicide, according to study findings.
A genetic liability for...
04/21/2025
Psych Congress Network
injection for schizophrenia treatment
News
04/21/2025
Maria Mantas
A meta-analysis of randomized controlled trials (RCTs) of antipsychotic monotherapy for the acute phase of schizophrenia and schizoaffective disorder (SSD) found that sedation onset peaked within the first 2 weeks of treatment initiation.
A meta-analysis of randomized controlled trials (RCTs) of antipsychotic monotherapy for the acute phase of schizophrenia and schizoaffective disorder (SSD) found that sedation onset peaked within the first 2 weeks of treatment initiation.
A meta-analysis of randomized...
04/21/2025
Psych Congress Network
older woman with depression
News
04/16/2025
Maria Mantas
A recent systematic review found weak quality evidence to support the effectiveness of several commonly prescribed pharmacological and non-pharmacological interventions for treatment-resistant depression (TRD) in older adults. 
A recent systematic review found weak quality evidence to support the effectiveness of several commonly prescribed pharmacological and non-pharmacological interventions for treatment-resistant depression (TRD) in older adults. 
A recent systematic review found...
04/16/2025
Psych Congress Network
Viloxazine Molecule
News
04/14/2025
Viloxazine ER is a nonstimulant medication for ADHD that has a unique mechanism of action compared to traditional stimulant medications, broadening the therapeutic landscape.
Viloxazine ER is a nonstimulant medication for ADHD that has a unique mechanism of action compared to traditional stimulant medications, broadening the therapeutic landscape.
Viloxazine ER is a nonstimulant...
04/14/2025
Psych Congress Network
an assortment of pills spilled out on a yellow table
News
04/14/2025
Jolynn Tumolo
According to randomized clinical trial findings, patients with opioid use disorder (OUD) who received inpatient addiction consultation service were more likely to initiate medication for OUD (MOUD) compared to those who received usual care.
According to randomized clinical trial findings, patients with opioid use disorder (OUD) who received inpatient addiction consultation service were more likely to initiate medication for OUD (MOUD) compared to those who received usual care.
According to randomized clinical...
04/14/2025
Psych Congress Network
Hormonal Contraceptive Pills
News
04/09/2025
Jolynn Tumolo
The initiation of hormonal contraception post partum was associated with an immediate increase in depression risk in first-time mothers in Denmark, according to a study published in JAMA Network Open.
The initiation of hormonal contraception post partum was associated with an immediate increase in depression risk in first-time mothers in Denmark, according to a study published in JAMA Network Open.
The initiation of hormonal...
04/09/2025
Psych Congress Network
A woman taking a pill
News
04/09/2025
Maria Mantas
Quetiapine may be more clinically effective than lithium as an augmentation option for reducing symptoms of treatment-resistant depression (TRD), a type of major depressive disorder (MDD), according to a recent study.
Quetiapine may be more clinically effective than lithium as an augmentation option for reducing symptoms of treatment-resistant depression (TRD), a type of major depressive disorder (MDD), according to a recent study.
Quetiapine may be more...
04/09/2025
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
Headshot of Snoben Kuruvila
Videos
04/24/2025
Following his insightful session at Psych Congress 2024, Snoben Kuruvila, MPAS, PA-C, sat down with Psych Congress Network to discuss emerging developments in major depressive disorder (MDD) treatment.
Following his insightful session at Psych Congress 2024, Snoben Kuruvila, MPAS, PA-C, sat down with Psych Congress Network to discuss emerging developments in major depressive disorder (MDD) treatment.
Following his insightful session...
04/24/2025
Psych Congress Network
headshot of Dr Craig Chepke
Videos
04/16/2025
Craig Chepke, MD, DFAPA
In this video, Craig Chepke, MD, DFAPA, discusses effective communication strategies clinicians can use when introducing long-acting injectable (LAI) antipsychotics to patients for the treatment of schizophrenia.
In this video, Craig Chepke, MD, DFAPA, discusses effective communication strategies clinicians can use when introducing long-acting injectable (LAI) antipsychotics to patients for the treatment of schizophrenia.
In this video, Craig Chepke, MD,...
04/16/2025
Psych Congress Network
headshot of Dr Mohamed Abdelwahab
Q&As
04/15/2025
Mohamed Abdelwahab, MD, PhD
Mohamed A. Abdelwahab, MD, PhD, discusses his recent meta-analysis comparing the mental health impacts of CPAP and surgical interventions.
Mohamed A. Abdelwahab, MD, PhD, discusses his recent meta-analysis comparing the mental health impacts of CPAP and surgical interventions.
Mohamed A. Abdelwahab, MD, PhD,...
04/15/2025
Psych Congress Network
headshot of Dr Julie Carbray
Q&As
04/11/2025
Julie A. Carbray, PhD, APRN
2025 Psych Congress NP Institute Co-Chair Julie Carbray, PhD, PMHNP-BC, PMHCNS-BC, APRN, shares how clinicians can best navigate between stimulant and nonstimulant treatment options for patients with ADHD.
2025 Psych Congress NP Institute Co-Chair Julie Carbray, PhD, PMHNP-BC, PMHCNS-BC, APRN, shares how clinicians can best navigate between stimulant and nonstimulant treatment options for patients with ADHD.
2025 Psych Congress NP Institute...
04/11/2025
Psych Congress NP Institute
Kristian Dambrino, MSN
Videos
04/08/2025
Kristian Dambrino, MSN, APRN, PMHNP
Psych Congress Faculty Member Kristian Dambrino, DNP, PMHNP-BC, dives into the nuances of prescribing vesicular monoamine transporter 2 (VMAT-2) inhibitors for the long-term management of TD.
Psych Congress Faculty Member Kristian Dambrino, DNP, PMHNP-BC, dives into the nuances of prescribing vesicular monoamine transporter 2 (VMAT-2) inhibitors for the long-term management of TD.
Psych Congress Faculty Member...
04/08/2025
Psych Congress Network
Thomas L. Schwartz, MD
Q&As
03/18/2025
Thomas L. Schwartz, MD, explores medicine’s evolving understanding of insomnia, narcolepsy, and idiopathic hypersomnia from a neuroscientific perspective.
Thomas L. Schwartz, MD, explores medicine’s evolving understanding of insomnia, narcolepsy, and idiopathic hypersomnia from a neuroscientific perspective.
Thomas L. Schwartz, MD, explores...
03/18/2025
Psych Congress Network
Brittany Albright
Q&As
03/11/2025
In part 2 of this Q and A, Brittany Albright, MD, MPH, Psych Congress Elevate faculty member and founder of Sweetgrass Psychiatry, discusses 2 of her favorite anhedonia treatment strategies.
In part 2 of this Q and A, Brittany Albright, MD, MPH, Psych Congress Elevate faculty member and founder of Sweetgrass Psychiatry, discusses 2 of her favorite anhedonia treatment strategies.
In part 2 of this Q and...
03/11/2025
Psych Congress Network
Dr Brittany Albright
Q&As
03/04/2025
In this Q&A, Psych Congress Elevate faculty member Dr Brittany Albright discusses the challenging symptoms of anhedonia and its significant impact on patients' quality of life and clinical outcomes.
In this Q&A, Psych Congress Elevate faculty member Dr Brittany Albright discusses the challenging symptoms of anhedonia and its significant impact on patients' quality of life and clinical outcomes.
In this Q&A, Psych Congress...
03/04/2025
Psych Congress Network
Examining Novel Treatment Methods in Schizophrenia
Videos
02/25/2025
Christoph U. Correll, MD
In this discussion, Christoph Correll, MD, professor of psychiatry at the Zucker School of Medicine, delves into the groundbreaking FDA approval of xanomeline/tropsium chloride, a novel treatment for schizophrenia that moves beyond...
In this discussion, Christoph Correll, MD, professor of psychiatry at the Zucker School of Medicine, delves into the groundbreaking FDA approval of xanomeline/tropsium chloride, a novel treatment for schizophrenia that moves beyond...
In this discussion, Christoph...
02/25/2025
Psych Congress Network
Steven Chan, MD, MBA, FAPA, FAMIA
Videos
02/14/2025
Steven Chan, MD, MBA
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

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
Expert Insights Quiz
Expert Insights Quiz
04/21/2025
Craig Chepke, MD, DFAPA
Which of the following strategies did Scientific Director for the Psych Congress event portfolio, Dr Craig Chepke, highlight as effective when introducing LAIs to patients with schizophrenia, including those in telemedicine settings?
Which of the following strategies did Scientific Director for the Psych Congress event portfolio, Dr Craig Chepke, highlight as effective when introducing LAIs to patients with schizophrenia, including those in telemedicine settings?
Which of the following...
04/21/2025
Psych Congress Network
a dialogue bubble with the word "quiz"
Quiz
04/21/2025
Do you remember the details of this study?
Do you remember the details of this study?
Do you remember the details of...
04/21/2025
Psych Congress Network
stacked blocks that spell out the word "quiz"
Quiz
04/17/2025
Test your knowledge of initial treatment approaches for adults in the acute phase of moderate to severe MDD in ambulatory care.
Test your knowledge of initial treatment approaches for adults in the acute phase of moderate to severe MDD in ambulatory care.
Test your knowledge of initial...
04/17/2025
Psych Congress Network
a sticky note that reads "take the quiz" stuck to a computer keyboard
Quiz
04/11/2025
According to a 2024 study, what impact did MHT use have on the risk of psychosis relapse in women between ages 40 and 55?
According to a 2024 study, what impact did MHT use have on the risk of psychosis relapse in women between ages 40 and 55?
According to a 2024 study, what...
04/11/2025
Psych Congress Network
an illustrated laptop screen displaying a quiz
Quiz
04/10/2025
According to provisional data from the Center for Disease Control and Prevention (CDC), by what percentage did US drug overdose deaths decrease in the 12 months ending in September 2024 compared to the previous year?
According to provisional data from the Center for Disease Control and Prevention (CDC), by what percentage did US drug overdose deaths decrease in the 12 months ending in September 2024 compared to the previous year?
According to provisional data...
04/10/2025
Psych Congress Network
Dr Steven Chan
Expert Insights Quiz
03/18/2025
Steven Chan, MD, MBA; Meagan Thistle
According to Psych Congress Steering Committee Member Steven Chan, MD, MBA, which of the following are important considerations when selecting and implementing digital therapeutics for the treatment of MDD?
According to Psych Congress Steering Committee Member Steven Chan, MD, MBA, which of the following are important considerations when selecting and implementing digital therapeutics for the treatment of MDD?
According to Psych Congress...
03/18/2025
Psych Congress Network
Did OUD diagnoses increase or decrease in VHA patients?
Quiz
02/25/2025
Do you remember the details of this study?
Do you remember the details of this study?
Do you remember the details of...
02/25/2025
Psych Congress Network
Charles Raison headshot
Expert Insights Quiz
02/21/2025
Charles L. Raison, MD
True or False: According to Psych Congress Steering Committee Member, Charles Raison, MD, the first-line treatment for primary insomnia is medication, including benzodiazepines.
True or False: According to Psych Congress Steering Committee Member, Charles Raison, MD, the first-line treatment for primary insomnia is medication, including benzodiazepines.
True or False: According to...
02/21/2025
Psych Congress Network
Quiz
Quiz
02/21/2025
Meagan Thistle
Is cariprazine FDA-approved as an adjunctive treatment for major depressive disorder (MDD)? What is another FDA-approved indication for this drug? Take the quiz to test your psychopharmacology knowledge!
Is cariprazine FDA-approved as an adjunctive treatment for major depressive disorder (MDD)? What is another FDA-approved indication for this drug? Take the quiz to test your psychopharmacology knowledge!
Is cariprazine FDA-approved as...
02/21/2025
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