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FDA Updates

Latest News

a rubber stamp says "FDA Approved"
FDA Alerts
10/09/2026
Brionna Mendoza
Teva Pharmaceuticals announced the FDA approval of subcutaneous olanzapine (Weltruza) for extended-release injectable suspension on October 9, 2026.
Teva Pharmaceuticals announced the FDA approval of subcutaneous olanzapine (Weltruza) for extended-release injectable suspension on October 9, 2026.
Teva Pharmaceuticals announced...
10/09/2026
Psych Congress Network
US FDA building
FDA Alerts
10/08/2026
Maria Mantas
The US Food and Drug Administration (FDA) granted 510(k) clearance for Motivista, the first treatment specifically authorized for negative symptoms of schizophrenia in adults.
The US Food and Drug Administration (FDA) granted 510(k) clearance for Motivista, the first treatment specifically authorized for negative symptoms of schizophrenia in adults.
The US Food and Drug...
10/08/2026
Psych Congress Network
US FDA sign
News
08/06/2026
Brionna Mendoza
The US FDA has approved oveporexton (ORZEYFUL), a first-in-class orexin treatment for narcolepsy type 1 (NT1) in adults.
The US FDA has approved oveporexton (ORZEYFUL), a first-in-class orexin treatment for narcolepsy type 1 (NT1) in adults.
The US FDA has approved...
08/06/2026
Psych Congress Network
FDA building
FDA Approval
07/27/2026
Maria Mantas
The US Food and Drug Administration (FDA) has approved centanafadine (SIMTRIYO), a norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI), for the treatment of attention-deficit/hyperactivity disorder (ADHD).
The US Food and Drug Administration (FDA) has approved centanafadine (SIMTRIYO), a norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI), for the treatment of attention-deficit/hyperactivity disorder (ADHD).
The US Food and Drug...
07/27/2026
Psych Congress Network
FDA approval stamp
FDA Alerts
07/16/2026
Maria Mantas
The US Food and Drug Administration (FDA) accepted Axsome Therapeutics’ New Drug Application (NDA) for AXS-12 (reboxetine) for cataplexy in narcolepsy.
The US Food and Drug Administration (FDA) accepted Axsome Therapeutics’ New Drug Application (NDA) for AXS-12 (reboxetine) for cataplexy in narcolepsy.
The US Food and Drug...
07/16/2026
Psych Congress Network
FDA building
FDA Alerts
06/11/2026
Maria Mantas
The US Food and Drug Administration (FDA) has cleared Wave Neuroscience’s Magnetic EEG-guided Resonance Therapy (MeRT) System, a biomarker-guided neuromodulation technology for the treatment of posttraumatic stress disorder (PTSD).
The US Food and Drug Administration (FDA) has cleared Wave Neuroscience’s Magnetic EEG-guided Resonance Therapy (MeRT) System, a biomarker-guided neuromodulation technology for the treatment of posttraumatic stress disorder (PTSD).
The US Food and Drug...
06/11/2026
Psych Congress Network
A lab tech handles psilocybin research
FDA Update
04/29/2026
Brionna Mendoza
Following an April 18 executive order, the US Food and Drug Administration (FDA) announced new regulatory actions to accelerate the development of psychedelic-assisted therapy for mental health conditions.
Following an April 18 executive order, the US Food and Drug Administration (FDA) announced new regulatory actions to accelerate the development of psychedelic-assisted therapy for mental health conditions.
Following an April 18 executive...
04/29/2026
Psych Congress Network
FDA approval stamp
FDA Alerts
04/27/2026
Maria Mantas
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for lumateperone (CAPLYTA) for relapse prevention in schizophrenia.
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for lumateperone (CAPLYTA) for relapse prevention in schizophrenia.
The US Food and Drug...
04/27/2026
Psych Congress Network
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
a woman holds a baby on her lap
Research Summary
11/05/2026
Maria Mantas
A self-led digital intervention targeting repetitive negative thinking significantly reduced anxiety during pregnancy and after childbirth, according to recent findings.
A self-led digital intervention targeting repetitive negative thinking significantly reduced anxiety during pregnancy and after childbirth, according to recent findings.
A self-led digital intervention...
11/05/2026
Psych Congress Network
intranasal spray bottles
Research Summary
11/02/2026
Brionna Mendoza
A single administration of mebufotenin benzoate nasal spray produced rapid, sustained reductions in depressive symptoms among adults with TRD, according to a phase 2b trial published in JAMA.
A single administration of mebufotenin benzoate nasal spray produced rapid, sustained reductions in depressive symptoms among adults with TRD, according to a phase 2b trial published in JAMA.
A single administration of...
11/02/2026
Psych Congress Network
A clinician fills out a form on a clipboard
News
10/26/2026
Brionna Mendoza
Investigational RAP-219 met the primary and secondary endpoints in a randomized, double-blind, placebo-controlled trial of adults experiencing acute bipolar mania, manufacturer Rapport Therapeutics announced on October 20, 2026.
Investigational RAP-219 met the primary and secondary endpoints in a randomized, double-blind, placebo-controlled trial of adults experiencing acute bipolar mania, manufacturer Rapport Therapeutics announced on October 20, 2026.
Investigational RAP-219 met the...
10/26/2026
Psych Congress Network
3D illustration of a brain in blue and white against a black background
Research Summary
10/21/2026
Brionna Mendoza
Home transcranial direct current stimulation paired with cognitive training delivered through a video game was feasible but offered no superior antidepressant benefit in a randomized clinical trial published in JAMA Network Open.
Home transcranial direct current stimulation paired with cognitive training delivered through a video game was feasible but offered no superior antidepressant benefit in a randomized clinical trial published in JAMA Network Open.
Home transcranial direct current...
10/21/2026
Psych Congress Network
a woman pours a pill from a pill bottle into her hand
Research Summary
10/15/2026
Maria Mantas
An individual participant data meta-analysis of 18 fixed-dose trials involving 7062 adults with acute schizophrenia found no evidence of sex differences in antipsychotic efficacy for overall symptom improvement.
An individual participant data meta-analysis of 18 fixed-dose trials involving 7062 adults with acute schizophrenia found no evidence of sex differences in antipsychotic efficacy for overall symptom improvement.
An individual participant data...
10/15/2026
Psych Congress Network
a rubber stamp says "FDA Approved"
FDA Alerts
10/09/2026
Brionna Mendoza
Teva Pharmaceuticals announced the FDA approval of subcutaneous olanzapine (Weltruza) for extended-release injectable suspension on October 9, 2026.
Teva Pharmaceuticals announced the FDA approval of subcutaneous olanzapine (Weltruza) for extended-release injectable suspension on October 9, 2026.
Teva Pharmaceuticals announced...
10/09/2026
Psych Congress Network
Head in profile with brain visible and target over brain
Research Summary
10/08/2026
Brionna Mendoza
A connectivity-guided approach to accelerated iTBS produced greater short-term reductions in depression severity than conventional scalp-based targeting.
A connectivity-guided approach to accelerated iTBS produced greater short-term reductions in depression severity than conventional scalp-based targeting.
A connectivity-guided approach...
10/08/2026
Psych Congress Network
US FDA building
FDA Alerts
10/08/2026
Maria Mantas
The US Food and Drug Administration (FDA) granted 510(k) clearance for Motivista, the first treatment specifically authorized for negative symptoms of schizophrenia in adults.
The US Food and Drug Administration (FDA) granted 510(k) clearance for Motivista, the first treatment specifically authorized for negative symptoms of schizophrenia in adults.
The US Food and Drug...
10/08/2026
Psych Congress Network
an illustration of a man sitting on the ground holding his head with his profile and brain in the background
Research Summary
10/06/2026
Brionna Mendoza
Young people beginning antipsychotic treatment after first-episode psychosis had low medication adherence, according to a retrospective US cohort study published in JAMA Network Open.
Young people beginning antipsychotic treatment after first-episode psychosis had low medication adherence, according to a retrospective US cohort study published in JAMA Network Open.
Young people beginning...
10/06/2026
Psych Congress Network
A selection of ultraprocessed foods, including donuts, hamburgers, pizza, and fries.
News
09/25/2026
Brionna Mendoza
Reducing ultraprocessed food consumption was feasible and acceptable among adults with major depressive disorder (MDD) and was associated with lower depression and anxiety scores.
Reducing ultraprocessed food consumption was feasible and acceptable among adults with major depressive disorder (MDD) and was associated with lower depression and anxiety scores.
Reducing ultraprocessed food...
09/25/2026
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
Kristian Dambrino, DNP, PMHNP-BC
Videos
11/03/2026
Kristian Dambrino, DNP, PMHNP, MSN
Kristian Dambrino, DNP, PMHNP-BC, explores how tardive dyskinesia considerations may influence antipsychotic treatment decisions in clinical practice.
Kristian Dambrino, DNP, PMHNP-BC, explores how tardive dyskinesia considerations may influence antipsychotic treatment decisions in clinical practice.
Kristian Dambrino, DNP,...
11/03/2026
Psych Congress Network
Kristian Dambrino, DNP, PMHNP-BC
Videos
11/03/2026
Kristian Dambrino, DNP, PMHNP, MSN
Kristian Dambrino, DNP, PMHNP-BC, explores how tardive dyskinesia considerations may influence antipsychotic treatment decisions in clinical practice.
Kristian Dambrino, DNP, PMHNP-BC, explores how tardive dyskinesia considerations may influence antipsychotic treatment decisions in clinical practice.
Kristian Dambrino, DNP,...
11/03/2026
Psych Congress Network
Melanie Barrett, MD
Videos
10/29/2026
Melanie Barrett, MD
Melanie Barrett, MD, discusses how mental health care providers can address gaps in postpartum depression screening, diagnosis, and treatment in clinical practice.
Melanie Barrett, MD, discusses how mental health care providers can address gaps in postpartum depression screening, diagnosis, and treatment in clinical practice.
Melanie Barrett, MD, discusses...
10/29/2026
Psych Congress Network
Mariela Podolski, MD, and James Somers, PA-C, DHSc, DFAAPA
Videos
10/22/2026
Mariela Podolski, MD; James C. Somers, DHSc, PA-C, DFAAPA
Psych Congress faculty members Mariela Podolski, MD, and James Somers, PA-C, DHSc, DFAAPA, discuss the relationship between nutrition and psychiatric outcomes.
Psych Congress faculty members Mariela Podolski, MD, and James Somers, PA-C, DHSc, DFAAPA, discuss the relationship between nutrition and psychiatric outcomes.
Psych Congress faculty members...
10/22/2026
Psych Congress Network
Kevin Williams, MS, MPAS, PA-C
Videos
10/05/2026
Kevin Williams, MS, MPAS, PA-C
Psych Congress PA Institute Co-Chair Kevin Williams, MS, MPAS, PA-C, explores how clinicians may incorporate the caregiver perspective into TD treatment, particularly when patients are unaware of their symptoms.
Psych Congress PA Institute Co-Chair Kevin Williams, MS, MPAS, PA-C, explores how clinicians may incorporate the caregiver perspective into TD treatment, particularly when patients are unaware of their symptoms.
Psych Congress PA Institute...
10/05/2026
Psych Congress Network
Kevin Williams, MS, MPAS, PA-C
Videos
10/05/2026
Kevin Williams, MS, MPAS, PA-C
Psych Congress PA Institute Co-Chair Kevin Williams, MS, MPAS, PA-C, explores how clinicians may incorporate the caregiver perspective into TD treatment, particularly when patients are unaware of their symptoms.
Psych Congress PA Institute Co-Chair Kevin Williams, MS, MPAS, PA-C, explores how clinicians may incorporate the caregiver perspective into TD treatment, particularly when patients are unaware of their symptoms.
Psych Congress PA Institute...
10/05/2026
Psych Congress Network
Kristian Dambrino, DNP, PMHNP-BC
Conference Insights
10/05/2026
Kristian Dambrino, DNP, PMHNP, MSN
Kristian Dambrino, DNP, PMHNP-BC, offers a framework for pinpointing when antidepressant nonresponse in MDD may be a byproduct of misdiagnosis.
Kristian Dambrino, DNP, PMHNP-BC, offers a framework for pinpointing when antidepressant nonresponse in MDD may be a byproduct of misdiagnosis.
Kristian Dambrino, DNP,...
10/05/2026
Psych Congress Network
Michael Asbach, DMsc, PA-C
Conference Insights
09/22/2026
Michael Asbach, DMSc, PA-C
Michael Asbach, DMSc, PA-C, Clinical Editor, Psych Congress Journal, explores key concepts from his Psych Congress 2026 session, “Could Glutamatergic Modulation be the Keystone of Durable Change in Treatment-Resistant Depression?”
Michael Asbach, DMSc, PA-C, Clinical Editor, Psych Congress Journal, explores key concepts from his Psych Congress 2026 session, “Could Glutamatergic Modulation be the Keystone of Durable Change in Treatment-Resistant Depression?”
Michael Asbach, DMSc, PA-C,...
09/22/2026
Psych Congress Network
Vladimir Maletic presents on stage
Videos
09/19/2026
The Dr Vladimir Maletic Memorial Scholarship was established to honor the life, legacy, and lasting influence of Dr Vladimir Maletic, a beloved member of the Psych Congress community and exceptional clinician and educator.
The Dr Vladimir Maletic Memorial Scholarship was established to honor the life, legacy, and lasting influence of Dr Vladimir Maletic, a beloved member of the Psych Congress community and exceptional clinician and educator.
The Dr Vladimir Maletic Memorial...
09/19/2026
Psych Congress Network
Julie Carbray, PhD, PMHNP-BC, and James Greenblatt, MD
Videos
09/18/2026
Julie Carbray PhD, PMHNP-BC, PMHCNS-BC, FAAN; James Greenblatt, MD
Julie Carbray, PhD, PMHNP-BC, FAAN, and James Greenblatt, MD, discuss how functional impairment, symptom severity, patient preferences, life stage, and family perspectives can shape initial ADHD treatment decisions, as explored at their 2026...
Julie Carbray, PhD, PMHNP-BC, FAAN, and James Greenblatt, MD, discuss how functional impairment, symptom severity, patient preferences, life stage, and family perspectives can shape initial ADHD treatment decisions, as explored at their 2026...
Julie Carbray, PhD, PMHNP-BC,...
09/18/2026
Psych Congress Network

Refresher Quizzes

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
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
Rakesh Jain, MD, MPH
Quiz
10/13/2026
Maria Mantas
According to an interview with Rakesh Jain, MD, MPH, what is a common mistake clinicians make when evaluating sleep complaints in patients with psychiatric disorders?
According to an interview with Rakesh Jain, MD, MPH, what is a common mistake clinicians make when evaluating sleep complaints in patients with psychiatric disorders?
According to an interview with...
10/13/2026
Psych Congress Network
illustration of a laptop screen displaying a test
Quiz
10/13/2026
Maria Mantas
Can you recall how biomarker-consistent antidepressant treatment compared to biomarker-inconsistent treatment?
Can you recall how biomarker-consistent antidepressant treatment compared to biomarker-inconsistent treatment?
Can you recall how...
10/13/2026
Psych Congress Network
pencil erasers that spell out the word "quiz"
Quiz
09/15/2026
Maria Mantas
Can you recall how iBTS compared to sham in addressing clinician-rated depressive symptoms among adults with MDD?
Can you recall how iBTS compared to sham in addressing clinician-rated depressive symptoms among adults with MDD?
Can you recall how iBTS compared...
09/15/2026
Psych Congress Network
Pop quiz written on a blackboard with white chalk
Quiz
09/09/2026
Brionna Mendoza
Test your treatment knowledge with this quiz!
Test your treatment knowledge with this quiz!
Test your treatment knowledge...
09/09/2026
Psych Congress Network
Craig Chepke, MD, DFAPA
Quiz
09/03/2026
Maria Mantas
Test your knowledge of VMAT2 inhibitor dosing!
Test your knowledge of VMAT2 inhibitor dosing!
Test your knowledge of VMAT2...
09/03/2026
Psych Congress Network
Craig Chepke, MD, DFAPA
Quiz
09/03/2026
Maria Mantas
Test your knowledge of VMAT2 inhibitor dosing!
Test your knowledge of VMAT2 inhibitor dosing!
Test your knowledge of VMAT2...
09/03/2026
Psych Congress Network
an illustrated laptop screen displaying a quiz
Quiz
08/26/2026
Maria Mantas
Can you recall which drug demonstrated the highest efficacy as adjunctive therapy for major depressive disorder?
Can you recall which drug demonstrated the highest efficacy as adjunctive therapy for major depressive disorder?
Can you recall which drug...
08/26/2026
Psych Congress Network
pencil erasers that spell out the word "quiz"
Quiz
08/25/2026
Maria Mantas
What is the recommended dosage of citalopram for older patients? Test your prescribing knowledge with this quiz!
What is the recommended dosage of citalopram for older patients? Test your prescribing knowledge with this quiz!
What is the recommended dosage...
08/25/2026
Psych Congress Network
Chelsie Monroe Expert Insights Quiz
Expert Insights Quiz
08/03/2026
Maria Mantas
What key characteristics can help clinicians differentiate fatigue from excessive daytime sleepiness in clinical practice?
What key characteristics can help clinicians differentiate fatigue from excessive daytime sleepiness in clinical practice?
What key characteristics can...
08/03/2026
Psych Congress Network
a printed test, pencil, and clock on a desk
Quiz
07/23/2026
Maria Mantas
Can you recall what the APA guideline recommends? Test yourself with this quick quiz!
Can you recall what the APA guideline recommends? Test yourself with this quick quiz!
Can you recall what the APA...
07/23/2026
Psych Congress Network